Last updated: 11/04/2018 11:36:39

Bipolar Study in Adults at Least 18 Years of Age

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GSK study ID
SCA40917
See study documents
Clinicaltrials.gov ID
NCT00067938
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Lamictal for use in treatment of Bipolar Disorder In Adults. A Practical Clinical Assessment of Tolerability and Clinical Effectiveness.
Trial description: Bipolar study of tolerability, clinical response and patient satisfaction
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

The primary endpoint will be the rate of rash during 12 weeks.

Timeframe: 12 Weeks

Secondary outcomes:

Change from baseline in Week 5 and Week 12 Clinical Global Impression-Bipolar version (CGI-BP) Severityand Improvement scores.

Timeframe: 12 Weeks

Interventions:
  • Drug: lamotrigine
    • Enrollment:
    1200
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Bipolar Disorder
    Product
    lamotrigine
    Collaborators
    Not applicable
    Study date(s)
    August 2003 to August 2004
    Type
    Interventional
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • Diagnosis of bipolar I disorder.
    • Must be on a stable regimen of psychiatric medication for at least 2 months prior to study.
    • Patients with a clinically significant psychiatric or physiologic comorbidity including significant substance abuse, depression or mania which is of an unstable of progressive nature that could interfere in participation of this study.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Diagnosis of bipolar I disorder.
    • Must be on a stable regimen of psychiatric medication for at least 2 months prior to study.
    • If female, must not be pregnant, or must be incapable of conceiving or be taking steps to prevent conception.
    Exclusion criteria:
    • Patients with a clinically significant psychiatric or physiologic comorbidity including significant substance abuse, depression or mania which is of an unstable of progressive nature that could interfere in participation of this study.
    • Presence of untreated thyroid disease.
    • Patient is actively suicidal or homicidal.
    • Patient has history of severe hepatic or renal insufficiency.
    • Patient is currently participating in another clinical trial.

    Trial location(s)

    Location
    Status
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    Location
    GSK Investigational Site
    Olean, New York, United States, 14760
    Status
    Study Complete
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    Location
    GSK Investigational Site
    La Mesa, California, United States, 91941
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Sacramento, California, United States, 95825
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Cerritos, California, United States, 90703
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    San Diego, California, United States, 92123
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Houston, Texas, United States, 77014
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Flowood, Mississippi, United States, 39232
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Birmingham, Alabama, United States, 35234
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Richmond, Virginia, United States, 23230
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Libertyville, Illinois, United States, 60048
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Natrona Heights, Pennsylvania, United States, 15065
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Raleigh, North Carolina, United States, 27605
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Palm Beach Gardens, Florida, United States, 33410
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Milwaukee, Wisconsin, United States, 53226
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Weirton, West Virginia, United States, 26062
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Winter Park, Florida, United States, 32789
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Bradenton, Florida, United States, 34209
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Oklahoma City, Oklahoma, United States, 73118
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Bristol, Tennessee, United States, 37620
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Ocala, Florida, United States, 34471
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Phoenix, Arizona, United States, 85032
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Charleston, South Carolina, United States, 29407
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Bellingham, Washington, United States, 98225
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Oakdale, Minnesota, United States, 55128
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Wilton Manors, Florida, United States, 33311
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Phoenix, Arizona, United States, 85018
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Houston, Texas, United States, 77057
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Houston, Texas, United States, 77027
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Bedford, Texas, United States, 76022
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Vernon Hills, Illinois, United States, 60061
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Fort Walton Beach, Florida, United States, 32548
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Charleston, West Virginia, United States, 25309
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Plantation, Florida, United States, 33324
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Tyler, Texas, United States, 75702
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Wethersfield, Connecticut, United States, 06109
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Plymouth, Indiana, United States, 46563
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Cary, North Carolina, United States, 27511
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Media, Pennsylvania, United States, 19063
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Port Jefferson, New York, United States, 11777
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Springfield, Missouri, United States, 65804
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Laurel, Maryland, United States, 20707
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Miami, Florida, United States, 33176
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Boca Raton, Florida, United States, 33433
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Renton, Washington, United States, 98055
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Avon Lake, Ohio, United States, 44012
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Farmington Hills, Michigan, United States, 48334
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Wheaton, Illinois, United States, 60187
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Oklahoma City, Oklahoma, United States, 73109
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Winter Park, Florida, United States, 32792
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Poway, California, United States, 92064
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    West Palm Beach, Florida, United States, 33407
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Austin, Texas, United States, 78759
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Gaithersburg, Maryland, United States, 20877
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Flint, Michigan, United States, 48532
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Baltimore, Maryland, United States, 21239
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Birmingham, Alabama, United States, 35209
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Long Branch, New Jersey, United States, 07740
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Houston, Texas, United States, 77042
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Raleigh, North Carolina, United States, 27607
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Tulsa, Oklahoma, United States, 74136
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Alton, Illinois, United States, 62002
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Park Ridge, Illinois, United States, 60068
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Wilmington, North Carolina, United States, 28401
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Coral Springs, Florida, United States, 33065
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Leavenworth, Kansas, United States, 66048
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Reading, Pennsylvania, United States, 19610
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Valparaiso, Indiana, United States, 46383
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Lexington, Kentucky, United States, 40509
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Knoxville, Tennessee, United States, 37919
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Oklahoma City, Oklahoma, United States, 73103
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    St. Louis, Missouri, United States, 63117
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Daytona Beach, Florida, United States, 32114
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Rochester Hills, Michigan, United States, 48307
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Milwaukie, Oregon, United States, 97222
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Burtonsville, Maryland, United States, 20866
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Adrian, Michigan, United States, 49221
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Miami, Florida, United States, 32216
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Chandler, Arizona, United States, 85225
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Chicago, Illinois, United States, 60657
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Baton Rouge, Louisiana, United States, 70806
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Fairfield, California, United States, 94533
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    San Diego, California, United States, 92114
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Stockbridge, Georgia, United States, 30281
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Fort Wayne, Indiana, United States, 46805
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Las Vegas, Nevada, United States, 89030
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Salt Lake City, Utah, United States, 84102
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Huntsville, Alabama, United States, 35802
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Greensboro, North Carolina, United States, 27408
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Wichita, Kansas, United States, 67207
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Raleigh, North Carolina, United States, 27612
    Status
    Study Complete
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    Location
    GSK Investigational Site
    High Point, North Carolina, United States, 27262
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Petaluma, California, United States, 94952
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Jacksonville Beach, Florida, United States, 32250
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Pensacola, Florida, United States, 32503
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Williston, Vermont, United States, 04495
    Status
    Study Complete
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    Location
    GSK Investigational Site
    New Rochelle, New York, United States, 10801
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Houston, Texas, United States, 77007
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Clinton Township, Michigan, United States, 48036
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Fairview Heights, Illinois, United States, 62208
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Henderson, Nevada, United States, 89074
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Cordova, Tennessee, United States, 38016
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Durham, North Carolina, United States, 27705
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Humble, Texas, United States, 77339
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Atlanta, Georgia, United States, 30030
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Shreveport, Louisiana, United States, 71101
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Humble, Texas, United States, 77338
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Duluth, Minnesota, United States, 55802
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Overland Park, Kansas, United States, 66211
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Orlando, Florida, United States, 32803
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Orland Park, Illinois, United States, 60462
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Madison, Tennessee, United States, 37115
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Cincinnati, Ohio, United States, 45206
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Nashville, Tennessee, United States, 37203
    Status
    Study Complete
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    Location
    GSK Investigational Site
    St. Petersburg, Florida, United States, 33702
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Wichita, Kansas, United States, 67206
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Doyletown, Pennsylvania, United States, 18901
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Billings, Montana, United States, 59101
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Princeton, New Jersey, United States, 08540
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Rockville, Maryland, United States, 20852
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Boulder, Colorado, United States, 80303
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Little Rock, Arkansas, United States, 72201
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Amityville, New York, United States, 11701
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Phoenix, Arizona, United States, 85044
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Racine, Wisconsin, United States, 53403
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Christiansburg, Virginia, United States, 24073
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Forest City, North Carolina, United States, 28043
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Charleston, West Virginia, United States, 25301
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Atlanta, Georgia, United States, 30338
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Tulsa, Oklahoma, United States, 74120
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Kingston, Pennsylvania, United States, 18704
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Las Vegas, Nevada, United States, 89102
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Altamonte Springs, Florida, United States, 32714
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Virginia Beach, Virginia, United States, 23452
    Status
    Will Be Recruiting
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    Location
    GSK Investigational Site
    Lawrenceville, Georgia, United States, 30045
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Schaumburg, Illinois, United States, 60194
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Mishawaka, Indiana, United States, 46545
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    New York, New York, United States, 10023
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Tampa, Florida, United States, 33603
    Status
    Study Complete
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    Location
    GSK Investigational Site
    McKeesport, Pennsylvania, United States, 15132
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Mansfield Center, Connecticut, United States, 06250
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Joplin, Missouri, United States, 64804
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Lafayette, Indiana, United States, 47904
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Clearwater, Florida, United States, 33764
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Evergreen Park, Illinois, United States, 60805
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Gulfport, Mississippi, United States, 39503
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Tucson, Arizona, United States, 85719
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    St. Petersburg, Florida, United States, 33701
    Status
    Study Complete
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    Location
    GSK Investigational Site
    San Diego, California, United States, 92103
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Glen Burnie, Maryland, United States, 21061
    Status
    Study Complete
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    Location
    GSK Investigational Site
    San Antonio, Texas, United States, 78229
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Philadelphia, Pennsylvania, United States, 19139
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Chapel Hill, North Carolina, United States, 27514
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Suffolk, Virginia, United States, 23434
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Chapel Hill, North Carolina, United States, 27517
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Syracuse, Florida, United States, 13202
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Granite City, Illinois, United States, 62040
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Boise, Idaho, United States, 83704
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Danville, Virginia, United States, 24541
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Moncks Corner, South Carolina, United States, 29461
    Status
    Study Complete
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    Location
    GSK Investigational Site
    St. Charles, Missouri, United States, 63301
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Fort Smith, Arkansas, United States, 72903
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Brandon, Florida, United States, 33511
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Charlottesville, Virginia, United States, 22903
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Sherman Oaks, California, United States, 91403
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Towson, Maryland, United States, 21286
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Kansas City, Missouri, United States, 64108
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Portland, Oregon, United States, 97210
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Annapolis, Maryland, United States, 21403
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Goldsboro, North Carolina, United States, 27530
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    North Charleston, South Carolina, United States, 29406
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Dayton, Ohio, United States, 45459
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Lincoln, Nebraska, United States, 68502
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Knoxville, Tennessee, United States, 37922
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Lakeland, Florida, United States, 33803
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    East Moline, Illinois, United States, 61244
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Casselberry, Florida, United States, 32730
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Norfolk, Virginia, United States, 23505
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Albany, New York, United States, 31701
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Wichita, Kansas, United States, 67211
    Status
    Study Complete
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    Location
    GSK Investigational Site
    San Jose, California, United States, 95123
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Ocala, Florida, United States, 34474
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Brownstown Township, Michigan, United States, 48183
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Oklahoma City, Oklahoma, United States, 73120
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Falls Church, Virginia, United States, 22041
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Evansville, Indiana, United States, 47715
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Omaha, Nebraska, United States, 68131
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Bay City, Michigan, United States, 48706
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Sarasota, Florida, United States, 34238
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Los Angeles, California, United States, 90011
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Cincinnati, Ohio, United States, 45243
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Lake Charles, Louisiana, United States, 70601
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Norwich, Connecticut, United States, 06360
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Greenville, North Carolina, United States, 27858
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Arlington, Virginia, United States, 22205
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Pittsburgh, Pennsylvania, United States, 15243
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Hopkinsville, Kentucky, United States, 42240
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Warner Robins, Georgia, United States, 31093
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Irving, Texas, United States, 75062
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Greenville, North Carolina, United States, 27834
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Smithtown, New York, United States, 11787
    Status
    Study Complete
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    Location
    GSK Investigational Site
    El Centro, California, United States, 92243
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Towson, Maryland, United States, 21204
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Kingwood, Texas, United States, 77339
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Orange City, Florida, United States, 32763
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Manchester, New Hampshire, United States, 03104
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    St. Louis, Missouri, United States, 63128
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Washington, District of Columbia, United States, 20011
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Lisle, Illinois, United States, 60532
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Macon, Georgia, United States, 31201
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Wichita, Kansas, United States, 67205
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Hamden, Connecticut, United States, 06514
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Colmar, Pennsylvania, United States, 18915
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Zephyrhills, Florida, United States, 33540
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    West Hollywood, California, United States, 90048
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Dubuque, Iowa, United States, 52001
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Farmingdale, New York, United States, 11735
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Wilmington, Delaware, United States, 19808
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Tuscaloosa, Alabama, United States, 35404
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Rockford, Illinois, United States, 61108
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Youngstown, Ohio, United States, 44512
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    East Lansing, Michigan, United States, 48823
    Status
    Study Complete
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    Location
    GSK Investigational Site
    North Miami, Florida, United States, 33161
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Houston, Texas, United States, 77030
    Status
    Terminated/Withdrawn
    Contact us
    Location
    GSK Investigational Site
    Miami, Florida, United States, 33125
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Houma, Louisiana, United States, 70360
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Fort Collins, Colorado, United States, 80525
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Mount Clemens, Michigan, United States, 48043
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Decatur, Georgia, United States, 30030
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Ellicott City, Maryland, United States, 21043
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Cedar Rapids, Iowa, United States, 52402
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Las Cruces, New Mexico, United States, 88011
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Topeka, Kansas, United States, 66606
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Dallas, Texas, United States, 75219
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Spokane, Washington, United States, 99204
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Bourbonnais, Illinois, United States, 60914
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Raleigh, North Carolina, United States, 27609
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Phoenix, Arizona, United States, 85004
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Shawnee Mission, Kansas, United States, 66214
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Houston, Texas, United States, 77074
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Jacksonville, Florida, United States, 32257
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Atlanta, Georgia, United States, 30309-7520
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Birmingham, Alabama, United States, 35223
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Charlotte, North Carolina, United States, 28211
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Bakersfield, California, United States, 93309
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Royal Oak, Michigan, United States, 48067
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Santa Ana, California, United States, 92705
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Joliet, Illinois, United States, 60435
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Waukesha, Wisconsin, United States, 53188
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Campbell, California, United States, 95008
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Murfreesboro, Tennessee, United States, 37129
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Tacoma, Washington, United States, 98499
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Arlington, Texas, United States, 76012
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Oakbrook Terrace, Illinois, United States, 60181
    Status
    Study Complete
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    Location
    GSK Investigational Site
    West Allis, Wisconsin, United States, 53227
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Minneapolis, Minnesota, United States, 55454
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Cuyahoga Falls, Ohio, United States, 44221
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Roswell, Georgia, United States, 30075
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Riverside, California, United States, 92506
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Bloomfield Hills, Michigan, United States, 48302
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Santa Barbara, California, United States, 93102
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Conroe, Texas, United States, 77304
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Batlimore, Maryland, United States, 21208
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Miami, Florida, United States, 33157
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Nacogdoches, Texas, United States, 75965
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Los Angeles, California, United States, 90089
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Sugar Land, Texas, United States, 77478
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Warren, Ohio, United States, 44483
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Mequion, Wisconsin, United States, 53092
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Rogers, Arizona, United States, 72756
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Kingsport, Tennessee, United States, 37664
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Wauwatosa, Wisconsin, United States, 53213
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Johnson City, Tennessee, United States, 37601
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Albuquerque, New Mexico, United States, 87108
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Boise, Idaho, United States, 83706
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Boynton Beach, Florida, United States, 33426
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Laguna Hills, California, United States, 92653
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Bronx, New York, United States, 10461
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Portsmouth, Virginia, United States, 23703
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Everett, Washington, United States, 98201
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    St. Louis, Missouri, United States, 63136-3675
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Albertville, Alabama, United States, 35950
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Beverly Hills, California, United States, 90210
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Newark, Delaware, United States, 19713
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Burbank, California, United States, 91501
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Nashville, Tennessee, United States, 37204
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Omaha, Nebraska, United States, 68124
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Oceanside, California, United States, 92056
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Fayetteville, North Carolina, United States, 28305
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Davie, Florida, United States, 33024
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Cornelius, North Carolina, United States, 28031
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Midlothian, Virginia, United States, 23112
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Newport News, Virginia, United States, 23606
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Boca Raton, Florida, United States, 33432
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Torrance, California, United States, 90505
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Benton Harbor, Michigan, United States, 49022
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Flint, Michigan, United States, 48507
    Status
    Study Complete
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    Location
    GSK Investigational Site
    San Antonio, Texas, United States, 78232
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Jacksonville, Florida, United States, 32216
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Gainesville, Florida, United States, 32607
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Danville, Indiana, United States, 46122
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Boise, Idaho, United States, 83702
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Fairhope, Alabama, United States, 36532
    Status
    Study Complete
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    Location
    GSK Investigational Site
    North Little Rock, Arkansas, United States, 72113
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Anniston, Alabama, United States, 36207
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Latham, New York, United States, 12110
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Destin, Florida, United States, 32541
    Status
    Terminated/Withdrawn
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    Location
    GSK Investigational Site
    Ashburn, Virginia, United States, 20147
    Status
    Study Complete
    Contact us

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    Not applicable
    Actual study completion date
    2004-05-08

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

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