Last updated: 11/04/2018 11:02:10

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

GSK study ID
S3B30048
See study documents
Clinicaltrials.gov ID
NCT00067457
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 12-Week, Randomized, Double-Blind, Placebo- Controlled Study of PRN BID and Fixed Dosing Regimens of Alosetron in Female Subjects with Severe Diarrhea-Predominant Irritable Bowel Syndrome Who Have Failed Conventional Therapy
Trial description: The purpose of this study is to compare the safety and effectiveness of as needed versus fixed dosing of an investigational medication for 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:

Subject self assessment of improvement between treatment groups using the IBS Global Improvement Scale; comparison of safety and tolerability between treatment groups with respect to adverse events & laboratory abnormalities.

Timeframe: 12 Weeks

Secondary outcomes:

Comparison of treatment groups with respect to subject relief of IBS pain & discomfort; lower GI symptoms, changes in quality of life, lost workplace productivity, & lost household/leisure activity, & subject satisfaction with assigned study drug.

Timeframe: 12 Weeks

Interventions:
  • Drug: alosetron
    • Enrollment:
    700
    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 December 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
    Norfolk, Virginia, United States, 23507
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Cincinnati, Ohio, United States, 45236
    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
    Richmond, Virginia, United States, 23294
    Status
    Recruiting
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    Location
    GSK Investigational Site
    Brooklyn Center, Minnesota, United States, 55430
    Status
    Recruiting
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    Location
    GSK Investigational Site
    Tucson, Arizona, United States, 85712
    Status
    Recruiting
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    Location
    GSK Investigational Site
    Indianapolis, Indiana, United States, 46208
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Madison, Wisconsin, United States, 53792
    Status
    Recruiting
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    Location
    GSK Investigational Site
    Boise, Idaho, United States, 83702
    Status
    Recruiting
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    GSK Investigational Site
    La Crosse, Wisconsin, United States, 54601
    Status
    Recruiting
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    Location
    GSK Investigational Site
    San Francisco, California, United States, 94115
    Status
    Recruiting
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    Location
    GSK Investigational Site
    Orange, California, United States, 92868
    Status
    Recruiting
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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
    Columbus, Ohio, United States, 43207
    Status
    Recruiting
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    GSK Investigational Site
    Philadelphia, Pennsylvania, United States, 19107
    Status
    Recruiting
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    GSK Investigational Site
    Baltimore, Maryland, United States, 21229
    Status
    Recruiting
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    GSK Investigational Site
    Penndel, Pennsylvania, United States, 19047
    Status
    Study Complete
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    GSK Investigational Site
    Bradenton, Florida, United States, 34209
    Status
    Study Complete
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    GSK Investigational Site
    Conroe, Texas, United States, 77304
    Status
    Study Complete
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    GSK Investigational Site
    Oklahoma City, Oklahoma, United States, 73112
    Status
    Will Be Recruiting
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    GSK Investigational Site
    Wichita, Kansas, United States, 67203
    Status
    Study Complete
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    GSK Investigational Site
    Albany, New York, United States, 12205
    Status
    Study Complete
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    GSK Investigational Site
    Houston, Texas, United States, 77024
    Status
    Study Complete
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    GSK Investigational Site
    San Antonio, Texas, United States, 78205
    Status
    Study Complete
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    GSK Investigational Site
    Wilmington, North Carolina, United States, 28401
    Status
    Recruiting
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    GSK Investigational Site
    Binghamton, New York, United States, 13901
    Status
    Recruiting
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    GSK Investigational Site
    Deland, Florida, United States, 32720
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    Charlotte, North Carolina, United States, 28262
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    Colorado Springs, Colorado, United States, 80909
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    Gastonia, North Carolina, United States, 28054
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    Greenville, North Carolina, United States, 27858
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    Bensalem, Pennsylvania, United States, 19020
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    San Diego, California, United States, 92108
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    GSK Investigational Site
    Longmont, Colorado, United States, 80501
    Status
    Study Complete
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    Blue Ridge, Georgia, United States, 30513
    Status
    Study Complete
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    Santa Ana, California, United States, 92704
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    Study Complete
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    Annapolis, Maryland, United States, 21401
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    Study Complete
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    GSK Investigational Site
    San Diego, California, United States, 92120
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    GSK Investigational Site
    Bellevue, Washington, United States, 98004
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    Study Complete
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    San Francisco, California, United States, 94114
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    Study Complete
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    Florence, Kentucky, United States, 41042
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    Summerville, South Carolina, United States, 29485
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    New Orleans, Louisiana, United States, 70112
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    GSK Investigational Site
    San Antonio, Texas, United States, 78229
    Status
    Study Complete
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    GSK Investigational Site
    Spring Hill, Florida, United States, 34608
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    GSK Investigational Site
    Libertyville, Illinois, United States, 60048
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    Study Complete
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    GSK Investigational Site
    Rome, Georgia, United States, 30165
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    GSK Investigational Site
    Fresno, California, United States, 93720
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    Wandsworth, Ohio, United States, 44281
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    Study Complete
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    Farmington Hills, Michigan, United States, 48334
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    Study Complete
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    Sioux Falls, South Dakota, United States, 57105
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    Mobile, Alabama, United States, 36693
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    Cedar Knolls, New Jersey, United States, 7927
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    GSK Investigational Site
    Birmingham, Alabama, United States, 35242
    Status
    Study Complete
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    GSK Investigational Site
    Concord, California, United States, 94520
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    GSK Investigational Site
    Sugar Land, Texas, United States, 77478
    Status
    Study Complete
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    GSK Investigational Site
    Moline, Illinois, United States, 61265
    Status
    Recruiting
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    GSK Investigational Site
    Bellbrook, Ohio, United States, 45305
    Status
    Study Complete
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    GSK Investigational Site
    Norfolk, Virginia, United States, 23502
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    GSK Investigational Site
    Memphis, Tennessee, United States, 38119
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    Stuart, Florida, United States, 34996
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    Chicago, Illinois, United States, 60612-7323
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    GSK Investigational Site
    Petoskey, Michigan, United States, 49770
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    Recruiting
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    GSK Investigational Site
    North Miami Beach, Florida, United States, 33162
    Status
    Will Be Recruiting
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    GSK Investigational Site
    Pittsburgh, Pennsylvania, United States, 15218
    Status
    Study Complete
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    GSK Investigational Site
    Knoxville, Tennessee, United States, 37920
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Humble, Texas, United States, 77338
    Status
    Will Be Recruiting
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    GSK Investigational Site
    Northville, Michigan, United States, 48167
    Status
    Study Complete
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    GSK Investigational Site
    Passaic, New Jersey, United States, 07055
    Status
    Recruiting
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    GSK Investigational Site
    Kingsport, Tennessee, United States, 37660
    Status
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    GSK Investigational Site
    Pell City, Alabama, United States, 35125
    Status
    Study Complete
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    GSK Investigational Site
    Kansas City, Kansas, United States, 66160
    Status
    Will Be Recruiting
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    GSK Investigational Site
    Beverly Hills, California, United States, 90211
    Status
    Study Complete
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    GSK Investigational Site
    Hollywood, Florida, United States, 33021
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    GSK Investigational Site
    Las Vegas, Nevada, United States, 89119
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    GSK Investigational Site
    Spring Valley, California, United States, 91978
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    Study Complete
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    GSK Investigational Site
    Monroe, Louisiana, United States, 71201
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    GSK Investigational Site
    Shreveport, Louisiana, United States, 71103
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    Recruiting
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    GSK Investigational Site
    Clearwater, Florida, United States, 33765
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    Study Complete
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    GSK Investigational Site
    Oxon Hill, Maryland, United States, 20745
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    GSK Investigational Site
    Boca Raton, Florida, United States, 33428
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    GSK Investigational Site
    Blackwood, New Jersey, United States, 08012
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    Recruiting
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    GSK Investigational Site
    Fayetteville, Georgia, United States, 30214
    Status
    Study Complete
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    GSK Investigational Site
    Morrisville, Pennsylvania, United States, 19067
    Status
    Will Be Recruiting
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    GSK Investigational Site
    Austin, Texas, United States, 78758
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    GSK Investigational Site
    Feasterville, Pennsylvania, United States, 19053
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    Chicago, Illinois, United States, 60637
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    GSK Investigational Site
    North Richland Hills, Texas, United States, 76180
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    GSK Investigational Site
    Stoneboro, Pennsylvania, United States, 16153
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    Study Complete
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    Nedlands, Western Australia, Australia, 27408
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    Duncansville, Pennsylvania, United States, 16635
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    Lacey, Washington, United States, 98516
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    Carlsbad, California, United States, 92008
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    Danville, Virginia, United States, 24541
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    GSK Investigational Site
    South Bound Brook, New Jersey, United States, 08880
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    Clive, Iowa, United States, 50325
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    Little Rock, Arkansas, United States, 72205
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    Gainesville, Florida, United States, 32607
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    GSK Investigational Site
    Jeffersonville, Indiana, United States, 47130
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    Jackson, Tennessee, United States, 38305
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    GSK Investigational Site
    Lanham, Maryland, United States, 20706
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    Wilmington, North Carolina, United States, 28412
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    GSK Investigational Site
    Rockford, Illinois, United States, 61107
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    Chesapeake, Virginia, United States, 23320
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    Reading, Pennsylvania, United States, 19611
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    GSK Investigational Site
    Raleigh, North Carolina, United States, 27609
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    GSK Investigational Site
    Covington, Louisiana, United States, 70433
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    GSK Investigational Site
    Clearwater, Florida, United States, 33756
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    Huntsville, Alabama, United States, 35801
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    GSK Investigational Site
    Tacoma, Washington, United States, 98405
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    Jacksonville, Florida, United States, 32209
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    Coeur D'Alene, Idaho, United States, 83814
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    Los Angeles, California, United States, 90035
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    Woodlands, Texas, United States, 77381
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    Dallas, Texas, United States, 75230
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    Levittown, Pennsylvania, United States, 19057
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    Silver Spring, Maryland, United States, 20910
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    Bristol, Connecticut, United States, 06010
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    Van Nuys, California, United States, 91405
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    Tallassee, Alabama, United States, 36078
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    Willingboro, New Jersey, United States, 08046
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    Madisonville, Kentucky, United States, 42431
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    Gig Harbor, Washington, United States, 98335
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    Clarksville, Tennessee, United States, 37043
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    Jacksonville, North Carolina, United States, 28546
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    Pasadena, Texas, United States, 77505
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    Towson, Maryland, United States, 21204
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    Great Neck, New York, United States, 11023
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    Littleton, Colorado, United States, 80120
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    Roseville, California, United States, 95661
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    Pomona, New York, United States, 10970
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    North Little Rock, Arkansas, United States, 72117
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    Saginaw, Michigan, United States, 48602
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    Jacksonville, Florida, United States, 32256-6004
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    Philadelphia, Pennsylvania, United States, 19106
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    Savannah, Georgia, United States, 31405
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    Haysville, Kansas, United States, 67060
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    Endwell, New York, United States, 13760
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    Portland, Oregon, United States, 97210
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    Nashville, Tennessee, United States, 37205
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    Albuquerque, New Mexico, United States, 87106
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    Meridian, Idaho, United States, 83642
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    Melbourne, Florida, United States, 32901
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    Morton Grove, Illinois, United States, 61550
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    Kissimmee, Florida, United States, 34741
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    Oakbrook Terrace, Illinois, United States, 60181
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    Towson, Maryland, United States, 21204-7736
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    Atlanta, Georgia, United States, 30339
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    Severna Park, Maryland, United States, 21146
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    Wheaton, Maryland, United States, 20906
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    Bristol, Tennessee, United States, 37620
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    Peoria, Illinois, United States, 61602
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    San Francisco, California, United States, 94122
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    Dunwoody, Georgia, United States, 30328
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    Pittsford, New York, United States, 14534
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    Chesterfield, Missouri, United States, 63017
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    Burlington, Massachusetts, United States, 01805
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    Tulsa, Oklahoma, United States, 74135
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    Oakhurst, New Jersey, United States, 07755
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    Lafayette, Louisiana, United States, 70508
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    Philadelphia, Pennsylvania, United States, 19148
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    Centennial, Colorado, United States, 80112
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    Lexington, Kentucky, United States, 40536
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    Garden Grove, California, United States, 92840
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    Atlanta, Georgia, United States, 30328
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    Birmingham, Alabama, United States, 35235
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    Sellersville, Pennsylvania, United States, 18960
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    Lincoln, Nebraska, United States, 68503
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    Cary, North Carolina, United States, 27511
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    Greensboro, North Carolina, United States, 27403
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    Lexington, Kentucky, United States, 40508
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    Weber City, Virginia, United States, 24290
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    Johnson City, Tennessee, United States, 37601
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    Torrance, California, United States, 90505
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    Belleair Bluffs, Florida, United States, 33770
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    Winston-Salem, North Carolina, United States, 27103
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    Salt Lake City, Utah, United States, 84132
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    Charleston, South Carolina, United States, 29407
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    Berlin, New Jersey, United States, 08009
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    Omaha, Nebraska, United States, 68144
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    New Orleans, Louisiana, United States, 70128
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    Location
    GSK Investigational Site
    Christiansburg, Virginia, United States, 24073
    Status
    Recruiting
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    Location
    GSK Investigational Site
    Encinitas, California, United States, 92024
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Zephyrhills, Florida, United States, 33540
    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
    St. Louis, Missouri, United States, 63141
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Virginia Beach, Virginia, United States, 23455
    Status
    Recruiting
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    Location
    GSK Investigational Site
    Anderson, South Carolina, United States, 29621
    Status
    Recruiting
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    Location
    GSK Investigational Site
    Columbus, Ohio, United States, 43215
    Status
    Study Complete
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    Location
    GSK Investigational Site
    Indianapolis, Indiana, United States, 46237
    Status
    Recruiting
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    Location
    GSK Investigational Site
    Portland, Oregon, United States, 97225
    Status
    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
    2005-28-12

    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
    Not applicable
    Participate in clinical trial
    Access to clinical trial data by researchers
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