Last updated: 11/04/2018 11:01:57

Study Of Women With Severe Diarrhea-Predominant Irritable Bowel Syndrome Having Failed Conventional Therapy

GSK study ID
S3B30040
See study documents
Clinicaltrials.gov ID
NCT00067561
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: A Twelve-Week, Randomized, Double Blind, Placebo-Controlled, Parallel-Group Study to Assess the Safety and Efficacy of 0.5 mg QD, 1 mg QD and 1 mg BID of Alosetron in Female Subjects with Severe Diarrhea-predominant IBS Who Have Failed Conventional Therapy
Trial description: The purpose of this study is to compare the safety and effectiveness of different doses of an investigational medication in women with severe diarrhea-predominant Irritable Bowel Syndrome (IBS) who have failed conventional therapy.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Not applicable
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
  • Drug: Alosetron
    • Enrollment:
    702
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Irritable Colon
    Product
    alosetron
    Collaborators
    Not applicable
    Study date(s)
    June 2003 to June 2005
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female
    Age
    18+ years
    Accepts healthy volunteers
    No
    • Diagnosed with severe diarrhea-predominant Irritable Bowel Syndrome (IBS).
    • Failed conventional therapy.
    • History of or current chronic or severe constipation.
    • Bloody diarrhea, abdominal pain with rectal bleeding.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Diagnosed with severe diarrhea-predominant Irritable Bowel Syndrome (IBS).
    • Failed conventional therapy.
    • Willing to make daily calls on a touch-tone telephone.
    Exclusion criteria:
    • History of or current chronic or severe constipation.
    • Bloody diarrhea, abdominal pain with rectal bleeding.
    • Thrombophlebitis.
    • Abnormal thyroid stimulating hormone (TSH) value.
    • Alcohol and/or substance abuse within past two years.
    • Pregnant or lactating.
    • History/treatment of malignancy within past five years.

    Trial location(s)

    Location
    Status
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    Location
    GSK Investigational Site
    Bismarck, North Dakota, United States, 58501
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Farmington, New Mexico, United States, 87401
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Bayshore, New York, United States, 11706
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Cleveland, Ohio, United States, 44113
    Status
    Recruiting
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    Location
    GSK Investigational Site
    New Port Richey, Florida, United States, 34652
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Bowling Green, Kentucky, United States, 42101
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Ocala, Florida, United States, 34471
    Status
    Study Complete
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    Location
    GSK Investigational Site
    San Diego, California, United States, 92123
    Status
    Recruiting
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    Location
    GSK Investigational Site
    Towson, Maryland, United States, 21204
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Houston, Texas, United States, 77030
    Status
    Will Be Recruiting
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    Location
    GSK Investigational Site
    Medford, Oregon, United States, 97504
    Status
    Recruiting
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    Location
    GSK Investigational Site
    East Providence, Rhode Island, United States, 02914
    Status
    Recruiting
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    Location
    GSK Investigational Site
    Hialeah, Florida, United States, 33013
    Status
    Study Complete
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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
    Boca Raton, Florida, United States, 33486
    Status
    Recruiting
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    Location
    GSK Investigational Site
    Miami, Florida, United States, 33186
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Englewood, Colorado, United States, 80113
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Bloomfield, New Jersey, United States, 07003
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Rochester, New York, United States, 14607
    Status
    Will Be Recruiting
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    Location
    GSK Investigational Site
    Cincinnati, Ohio, United States, 45224
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Jefferson City, Missouri, United States, 65109
    Status
    Recruiting
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    Location
    GSK Investigational Site
    Dallas, Texas, United States, 75204
    Status
    Recruiting
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    Location
    GSK Investigational Site
    Columbia, South Carolina, United States, 29240
    Status
    Recruiting
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    Location
    GSK Investigational Site
    Fleetwood, Pennsylvania, United States, 19522
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Lake Worth, Florida, United States, 33461
    Status
    Recruiting
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    Location
    GSK Investigational Site
    Egg Harbor Township, New Jersey, United States, 08234
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Winston-Salem, North Carolina, United States, 27103
    Status
    Recruiting
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    Location
    GSK Investigational Site
    Newport Beach, California, United States, 92663
    Status
    Recruiting
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    Location
    GSK Investigational Site
    Spokane, Washington, United States, 99207
    Status
    Recruiting
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    Location
    GSK Investigational Site
    Chula Vista, California, United States, 91910
    Status
    Recruiting
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    Location
    GSK Investigational Site
    Tuscaloosa, Alabama, United States, 35406
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Morehead City, North Carolina, United States, 28557
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Martinez, Georgia, United States, 30907
    Status
    Recruiting
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    Location
    GSK Investigational Site
    Murfreesboro, Tennessee, United States, 37130
    Status
    Recruiting
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    Location
    GSK Investigational Site
    High Point, North Carolina, United States, 27262
    Status
    Recruiting
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    Location
    GSK Investigational Site
    Decatur, Georgia, United States, 30033
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Rancho Cucamonga, California, United States, 91730
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Lancaster, California, United States, 93534
    Status
    Recruiting
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    Location
    GSK Investigational Site
    Tampa, Florida, United States, 33614
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Raleigh, North Carolina, United States, 27609
    Status
    Recruiting
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    Location
    GSK Investigational Site
    Austell, Georgia, United States, 30106
    Status
    Recruiting
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    Location
    GSK Investigational Site
    Vista, California, United States, 92084
    Status
    Recruiting
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    Location
    GSK Investigational Site
    Beavercreek, Ohio, United States, 45431
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Milwaukee, Wisconsin, United States, 53215
    Status
    Recruiting
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    Location
    GSK Investigational Site
    Akron, Ohio, United States, 44302
    Status
    Recruiting
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    Location
    GSK Investigational Site
    Redlands, California, United States, 92373
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Charlottesville, Virginia, United States, 22911
    Status
    Recruiting
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    Location
    GSK Investigational Site
    Lacey, Washington, United States, 98516
    Status
    Recruiting
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    Location
    GSK Investigational Site
    Newtown, Pennsylvania, United States, 18940
    Status
    Recruiting
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    Location
    GSK Investigational Site
    Wheat Ridge, Colorado, United States, 80033
    Status
    Recruiting
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    Location
    GSK Investigational Site
    Ann Arbor, Michigan, United States, 48109
    Status
    Will Be Recruiting
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    Location
    GSK Investigational Site
    Oklahoma City, Oklahoma, United States, 73112
    Status
    Recruiting
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    Location
    GSK Investigational Site
    Atlanta, Georgia, United States, 30328
    Status
    Study Complete
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    Location
    GSK Investigational Site
    South Bend, Indiana, United States, 46601
    Status
    Recruiting
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    Location
    GSK Investigational Site
    Fort Myers, Florida, United States, 33907
    Status
    Recruiting
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    Location
    GSK Investigational Site
    Corpus Christi, Texas, United States, 78412
    Status
    Recruiting
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    Location
    GSK Investigational Site
    Jefferson City, Missouri, United States, 65101
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Peoria, Illinois, United States, 61602
    Status
    Recruiting
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    Location
    GSK Investigational Site
    Indianapolis, Indiana, United States, 46254
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Ocean, New Jersey, United States, 7712
    Status
    Recruiting
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    Location
    GSK Investigational Site
    Overland Park, Kansas, United States, 66211
    Status
    Recruiting
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    Location
    GSK Investigational Site
    Greenville, South Carolina, United States, 29615
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Louisville, Kentucky, United States, 40291
    Status
    Recruiting
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    Location
    GSK Investigational Site
    Riverside, Illinois, United States, 60546
    Status
    Recruiting
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    Location
    GSK Investigational Site
    Kingsport, Tennessee, United States, 37660
    Status
    Will Be Recruiting
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    Location
    GSK Investigational Site
    Dayton, Ohio, United States, 45440
    Status
    Recruiting
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    Location
    GSK Investigational Site
    Garden Grove, California, United States, 92840
    Status
    Recruiting
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    Location
    GSK Investigational Site
    Yakima, Washington, United States, 98902
    Status
    Recruiting
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    Location
    GSK Investigational Site
    Grand Rapids, Michigan, United States, 49546
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Boynton Beach, Florida, United States, 33437
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Milwaukee, Wisconsin, United States, 53209-0996
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Wentzville, Minnesota, United States, 62285
    Status
    Recruiting
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    Location
    GSK Investigational Site
    Longwood, Florida, United States, 32779
    Status
    Recruiting
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    Location
    GSK Investigational Site
    Manchester, Connecticut, United States, 06040
    Status
    Recruiting
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    Location
    GSK Investigational Site
    Pittsburgh, Pennsylvania, United States, 15212
    Status
    Recruiting
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    Location
    GSK Investigational Site
    Phoenix, Arizona, United States, 85006
    Status
    Recruiting
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    Location
    GSK Investigational Site
    Laurel, Maryland, United States, 20707
    Status
    Recruiting
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    Location
    GSK Investigational Site
    Silver Spring, Maryland, United States, 20901
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Wyomissing, Pennsylvania, United States, 19610
    Status
    Recruiting
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    Location
    GSK Investigational Site
    Fort Myers, Florida, United States, 33916
    Status
    Recruiting
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    Location
    GSK Investigational Site
    Nashville, Tennessee, United States, 37203
    Status
    Recruiting
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    Location
    GSK Investigational Site
    Austin, Texas, United States, 78745
    Status
    Recruiting
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    Location
    GSK Investigational Site
    Simpsonville, South Carolina, United States, 29681
    Status
    Recruiting
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    Location
    GSK Investigational Site
    Arlington, Texas, United States, 76012
    Status
    Recruiting
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    Location
    GSK Investigational Site
    West Jordan, Utah, United States, 84088
    Status
    Recruiting
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    Location
    GSK Investigational Site
    Chesapeake, Virginia, United States, 23320
    Status
    Recruiting
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    Location
    GSK Investigational Site
    Atlanta, Georgia, United States, 30342
    Status
    Study Complete
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    Location
    GSK Investigational Site
    San Antonio, Texas, United States, 78205
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Jackson, Mississippi, United States, 39202
    Status
    Recruiting
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    Location
    GSK Investigational Site
    Humble, Texas, United States, 77338
    Status
    Recruiting
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    Location
    GSK Investigational Site
    Wenatchee, Washington, United States, 98801
    Status
    Recruiting
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    Location
    GSK Investigational Site
    Boulder, Colorado, United States, 80304
    Status
    Recruiting
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    Location
    GSK Investigational Site
    Alexandria, Virginia, United States, 22304
    Status
    Recruiting
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    Location
    GSK Investigational Site
    Tulsa, Oklahoma, United States, 74136
    Status
    Recruiting
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    Location
    GSK Investigational Site
    Stony Brook, New York, United States, 11794-8091
    Status
    Recruiting
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    Location
    GSK Investigational Site
    Kettering, Ohio, United States, 45429
    Status
    Recruiting
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    Location
    GSK Investigational Site
    Walla Walla, Washington, United States, 99362
    Status
    Recruiting
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    Location
    GSK Investigational Site
    Zephyrhills, Florida, United States, 33540
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Santa Ana, California, United States, 92704
    Status
    Recruiting
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    Location
    GSK Investigational Site
    San Rafael, California, United States, 94901
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Memphis, Tennessee, United States, 38120
    Status
    Recruiting
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    Location
    GSK Investigational Site
    St. Joseph, Michigan, United States, 49085
    Status
    Recruiting
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    Location
    GSK Investigational Site
    San Diego, California, United States, 92103
    Status
    Will Be Recruiting
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    Location
    GSK Investigational Site
    Kansas City, Missouri, United States, 64131
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Tomball, Texas, United States, 77375
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Calera, Alabama, United States, 35040
    Status
    Recruiting
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    Location
    GSK Investigational Site
    Hickory, North Carolina, United States, 28601
    Status
    Recruiting
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    Location
    GSK Investigational Site
    Oak Park, Michigan, United States, 48237
    Status
    Recruiting
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    Location
    GSK Investigational Site
    Lyndhurst, Ohio, United States, 44124
    Status
    Study Complete
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    Location
    GSK Investigational Site
    St. Paul, Minnesota, United States, 55435
    Status
    Recruiting
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    Location
    GSK Investigational Site
    Oklahoma City, Oklahoma, United States, 73104
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Baltimore, Maryland, United States, 21215
    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
    Los Angeles, California, United States, 90045
    Status
    Recruiting
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    Location
    GSK Investigational Site
    Altoona, Pennsylvania, United States, 16602
    Status
    Recruiting
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    GSK Investigational Site
    Cleveland, Ohio, United States, 44106
    Status
    Recruiting
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    GSK Investigational Site
    San Antonio, Texas, United States, 78229
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    Recruiting
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    GSK Investigational Site
    Memphis, Tennessee, United States, 38119
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    Recruiting
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    GSK Investigational Site
    Columbus, Ohio, United States, 43212
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    Recruiting
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    GSK Investigational Site
    West Palm Beach, Florida, United States, 33407
    Status
    Recruiting
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    GSK Investigational Site
    Cary, North Carolina, United States, 27511
    Status
    Recruiting
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    GSK Investigational Site
    Colorado Springs, Colorado, United States, 80909
    Status
    Recruiting
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    GSK Investigational Site
    Great Neck, New York, United States, 11023
    Status
    Recruiting
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    GSK Investigational Site
    St. Petersburg, Florida, United States, 33702
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Chapel Hill, North Carolina, United States, 27599
    Status
    Recruiting
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    GSK Investigational Site
    Chaska, Minnesota, United States, 55318
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    GSK Investigational Site
    Fountain Valley, California, United States, 92708
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    GSK Investigational Site
    Irving, Texas, United States, 75061
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    Recruiting
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    GSK Investigational Site
    Milwaukee, Wisconsin, United States, 53212
    Status
    Recruiting
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    GSK Investigational Site
    Cincinnati, Ohio, United States, 45219
    Status
    Recruiting
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    GSK Investigational Site
    Lebanon, New Hampshire, United States, 03756
    Status
    Recruiting
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    GSK Investigational Site
    Savannah, Georgia, United States, 31405
    Status
    Recruiting
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    GSK Investigational Site
    Tallahassee, Florida, United States, 32308
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Cincinnati, Ohio, United States, 45220
    Status
    Recruiting
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    GSK Investigational Site
    Vineland, New Jersey, United States, 8360
    Status
    Recruiting
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    GSK Investigational Site
    Naples, Florida, United States, 34102
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    Study Complete
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    GSK Investigational Site
    Nedlands, Western Australia, Australia, 27408
    Status
    Recruiting
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    GSK Investigational Site
    Madisonville, Kentucky, United States, 42431
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    GSK Investigational Site
    Coral Gables, Florida, United States, 33134
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    GSK Investigational Site
    Syracuse, New York, United States, 13210
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    Recruiting
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    GSK Investigational Site
    Boston, Massachusetts, United States, 02114
    Status
    Study Complete
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    GSK Investigational Site
    Bountiful, Utah, United States, 84010
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    Recruiting
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    GSK Investigational Site
    Davenport, Louisiana, United States, 52807
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    Recruiting
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    GSK Investigational Site
    Silver Spring, Maryland, United States, 20910
    Status
    Study Complete
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    GSK Investigational Site
    Lancaster, Pennsylvania, United States, 19096
    Status
    Will Be Recruiting
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    GSK Investigational Site
    Panama City, Florida, United States, 32405
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    Recruiting
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    GSK Investigational Site
    Indianapolis, Indiana, United States, 46250
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    Recruiting
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    GSK Investigational Site
    Bristol, Tennessee, United States, 37620
    Status
    Recruiting
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    GSK Investigational Site
    Merrick, New York, United States, 11566
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    Study Complete
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    GSK Investigational Site
    Tucson, Arizona, United States, 85723
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    Study Complete
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    GSK Investigational Site
    Upland, California, United States, 91786
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    Study Complete
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    Warren, Michigan, United States, 48089
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    Study Complete
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    GSK Investigational Site
    Marietta, Georgia, United States, 30060
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    Fayetteville, Arkansas, United States, 72701
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    Study Complete
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    GSK Investigational Site
    Ogden, Utah, United States, 84405
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    Recruiting
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    GSK Investigational Site
    Birmingham, Alabama, United States, 35235
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    Recruiting
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    GSK Investigational Site
    Milwaukee, Wisconsin, United States, 53226
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    Study Complete
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    GSK Investigational Site
    Boynton Beach, Florida, United States, 33426
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    Recruiting
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    GSK Investigational Site
    Hollywood, Florida, United States, 33021
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    Recruiting
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    GSK Investigational Site
    Boston, Massachusetts, United States, 02215
    Status
    Recruiting
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    GSK Investigational Site
    Charlotte, North Carolina, United States, 28207
    Status
    Recruiting
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    GSK Investigational Site
    Colorado Springs, Colorado, United States, 80907
    Status
    Study Complete
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    GSK Investigational Site
    Houston, Texas, United States, 77024
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    GSK Investigational Site
    West Caldwell, New Jersey, United States, 7006
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    Greenville, North Carolina, United States, 27858
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    GSK Investigational Site
    Atlanta, Georgia, United States, 30309
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    Recruiting
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    Location
    GSK Investigational Site
    Miami, Florida, United States, 33156
    Status
    Study Complete
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    GSK Investigational Site
    Attleboro, Massachusetts, United States, 2703
    Status
    Recruiting
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    GSK Investigational Site
    Detroit, Michigan, United States, 48202
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Yuba City, California, United States, 95991
    Status
    Study Complete
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    GSK Investigational Site
    Houston, Texas, United States, 77025
    Status
    Study Complete
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    GSK Investigational Site
    Fayetteville, North Carolina, United States, 28304
    Status
    Recruiting
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    GSK Investigational Site
    Sarasota, Florida, United States, 34232
    Status
    Study Complete
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    GSK Investigational Site
    Missoula, Montana, United States, 59802
    Status
    Study Complete
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    GSK Investigational Site
    Charlottesville, Virginia, United States, 22908
    Status
    Recruiting
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    GSK Investigational Site
    Louisville, Kentucky, United States, 40202
    Status
    Recruiting
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    GSK Investigational Site
    Asheville, North Carolina, United States, 28801
    Status
    Recruiting
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    Location
    GSK Investigational Site
    Hershey, Pennsylvania, United States, 17033
    Status
    Will Be Recruiting
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    Study documents

    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
    2005-01-06

    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

    Additional information
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