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
Completed
Completed
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
Observational study model:
Not applicable
Primary completion date:
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)

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GSK Investigational Site
Norfolk, Virginia, United States, 23507
Status
Study Complete
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Cincinnati, Ohio, United States, 45236
Status
Study Complete
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GSK Investigational Site
Media, Pennsylvania, United States, 19063
Status
Study Complete
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GSK Investigational Site
Richmond, Virginia, United States, 23294
Status
Recruiting
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Brooklyn Center, Minnesota, United States, 55430
Status
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Tucson, Arizona, United States, 85712
Status
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GSK Investigational Site
Indianapolis, Indiana, United States, 46208
Status
Study Complete
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Madison, Wisconsin, United States, 53792
Status
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Boise, Idaho, United States, 83702
Status
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La Crosse, Wisconsin, United States, 54601
Status
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GSK Investigational Site
San Francisco, California, United States, 94115
Status
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Location
GSK Investigational Site
Orange, California, United States, 92868
Status
Recruiting
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GSK Investigational Site
San Diego, California, United States, 92103
Status
Study Complete
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GSK Investigational Site
Columbus, Ohio, United States, 43207
Status
Recruiting
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Location
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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Location
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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Location
GSK Investigational Site
Conroe, Texas, United States, 77304
Status
Study Complete
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Location
GSK Investigational Site
Oklahoma City, Oklahoma, United States, 73112
Status
Will Be Recruiting
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Location
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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San Antonio, Texas, United States, 78205
Status
Study Complete
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Location
GSK Investigational Site
Wilmington, North Carolina, United States, 28401
Status
Recruiting
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Binghamton, New York, United States, 13901
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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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GSK Investigational Site
Gastonia, North Carolina, United States, 28054
Status
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Greenville, North Carolina, United States, 27858
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Recruiting
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GSK Investigational Site
Bensalem, Pennsylvania, United States, 19020
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GSK Investigational Site
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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GSK Investigational Site
Blue Ridge, Georgia, United States, 30513
Status
Study Complete
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Santa Ana, California, United States, 92704
Status
Study Complete
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GSK Investigational Site
Annapolis, Maryland, United States, 21401
Status
Study Complete
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GSK Investigational Site
San Diego, California, United States, 92120
Status
Recruiting
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GSK Investigational Site
Bellevue, Washington, United States, 98004
Status
Study Complete
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GSK Investigational Site
San Francisco, California, United States, 94114
Status
Study Complete
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GSK Investigational Site
Florence, Kentucky, United States, 41042
Status
Recruiting
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GSK Investigational Site
Summerville, South Carolina, United States, 29485
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Recruiting
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GSK Investigational Site
New Orleans, Louisiana, United States, 70112
Status
Will Be Recruiting
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GSK Investigational Site
San Antonio, Texas, United States, 78229
Status
Study Complete
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Location
GSK Investigational Site
Spring Hill, Florida, United States, 34608
Status
Recruiting
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GSK Investigational Site
Libertyville, Illinois, United States, 60048
Status
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
Status
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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Recruiting
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Mobile, Alabama, United States, 36693
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GSK Investigational Site
Cedar Knolls, New Jersey, United States, 7927
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Recruiting
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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
Status
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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
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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
Status
Recruiting
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Location
GSK Investigational Site
Memphis, Tennessee, United States, 38119
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GSK Investigational Site
Stuart, Florida, United States, 34996
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GSK Investigational Site
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
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Study Complete
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GSK Investigational Site
Humble, Texas, United States, 77338
Status
Will Be Recruiting
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Location
GSK Investigational Site
Northville, Michigan, United States, 48167
Status
Study Complete
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GSK Investigational Site
Passaic, New Jersey, United States, 07055
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GSK Investigational Site
Kingsport, Tennessee, United States, 37660
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GSK Investigational Site
Pell City, Alabama, United States, 35125
Status
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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
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Study Complete
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GSK Investigational Site
Hollywood, Florida, United States, 33021
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Study Complete
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GSK Investigational Site
Las Vegas, Nevada, United States, 89119
Status
Recruiting
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GSK Investigational Site
Spring Valley, California, United States, 91978
Status
Study Complete
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Location
GSK Investigational Site
Monroe, Louisiana, United States, 71201
Status
Study Complete
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GSK Investigational Site
Shreveport, Louisiana, United States, 71103
Status
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GSK Investigational Site
Clearwater, Florida, United States, 33765
Status
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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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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Location
GSK Investigational Site
Austin, Texas, United States, 78758
Status
Recruiting
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Location
GSK Investigational Site
Feasterville, Pennsylvania, United States, 19053
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GSK Investigational Site
Chicago, Illinois, United States, 60637
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Study Complete
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Location
GSK Investigational Site
North Richland Hills, Texas, United States, 76180
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Recruiting
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Location
GSK Investigational Site
Stoneboro, Pennsylvania, United States, 16153
Status
Study Complete
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Location
GSK Investigational Site
Nedlands, Western Australia, Australia, 27408
Status
Recruiting
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Location
GSK Investigational Site
Duncansville, Pennsylvania, United States, 16635
Status
Recruiting
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Location
GSK Investigational Site
Lacey, Washington, United States, 98516
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GSK Investigational Site
Carlsbad, California, United States, 92008
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Study Complete
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GSK Investigational Site
Danville, Virginia, United States, 24541
Status
Recruiting
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Location
GSK Investigational Site
South Bound Brook, New Jersey, United States, 08880
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Study Complete
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Location
GSK Investigational Site
Clive, Iowa, United States, 50325
Status
Recruiting
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Location
GSK Investigational Site
Little Rock, Arkansas, United States, 72205
Status
Study Complete
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Location
GSK Investigational Site
Gainesville, Florida, United States, 32607
Status
Recruiting
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Location
GSK Investigational Site
Jeffersonville, Indiana, United States, 47130
Status
Study Complete
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Location
GSK Investigational Site
Jackson, Tennessee, United States, 38305
Status
Recruiting
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Location
GSK Investigational Site
Lanham, Maryland, United States, 20706
Status
Study Complete
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Location
GSK Investigational Site
Wilmington, North Carolina, United States, 28412
Status
Recruiting
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Location
GSK Investigational Site
Rockford, Illinois, United States, 61107
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GSK Investigational Site
Chesapeake, Virginia, United States, 23320
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Location
GSK Investigational Site
Reading, Pennsylvania, United States, 19611
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Location
GSK Investigational Site
Raleigh, North Carolina, United States, 27609
Status
Study Complete
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Location
GSK Investigational Site
Covington, Louisiana, United States, 70433
Status
Recruiting
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Location
GSK Investigational Site
Clearwater, Florida, United States, 33756
Status
Study Complete
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Location
GSK Investigational Site
Huntsville, Alabama, United States, 35801
Status
Recruiting
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Location
GSK Investigational Site
Tacoma, Washington, United States, 98405
Status
Recruiting
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Location
GSK Investigational Site
Jacksonville, Florida, United States, 32209
Status
Study Complete
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Location
GSK Investigational Site
Coeur D'Alene, Idaho, United States, 83814
Status
Study Complete
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Location
GSK Investigational Site
Los Angeles, California, United States, 90035
Status
Study Complete
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Location
GSK Investigational Site
Woodlands, Texas, United States, 77381
Status
Study Complete
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GSK Investigational Site
Dallas, Texas, United States, 75230
Status
Recruiting
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Location
GSK Investigational Site
Levittown, Pennsylvania, United States, 19057
Status
Study Complete
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GSK Investigational Site
Silver Spring, Maryland, United States, 20910
Status
Recruiting
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GSK Investigational Site
Bristol, Connecticut, United States, 06010
Status
Recruiting
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Location
GSK Investigational Site
Van Nuys, California, United States, 91405
Status
Study Complete
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Location
GSK Investigational Site
Tallassee, Alabama, United States, 36078
Status
Recruiting
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Location
GSK Investigational Site
Willingboro, New Jersey, United States, 08046
Status
Study Complete
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Location
GSK Investigational Site
Madisonville, Kentucky, United States, 42431
Status
Recruiting
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Location
GSK Investigational Site
Gig Harbor, Washington, United States, 98335
Status
Study Complete
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Location
GSK Investigational Site
Clarksville, Tennessee, United States, 37043
Status
Study Complete
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Location
GSK Investigational Site
Jacksonville, North Carolina, United States, 28546
Status
Study Complete
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GSK Investigational Site
Pasadena, Texas, United States, 77505
Status
Study Complete
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GSK Investigational Site
Towson, Maryland, United States, 21204
Status
Study Complete
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GSK Investigational Site
Great Neck, New York, United States, 11023
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Study Complete
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GSK Investigational Site
Littleton, Colorado, United States, 80120
Status
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GSK Investigational Site
Roseville, California, United States, 95661
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GSK Investigational Site
Pomona, New York, United States, 10970
Status
Study Complete
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GSK Investigational Site
North Little Rock, Arkansas, United States, 72117
Status
Study Complete
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Location
GSK Investigational Site
Saginaw, Michigan, United States, 48602
Status
Study Complete
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GSK Investigational Site
Jacksonville, Florida, United States, 32256-6004
Status
Recruiting
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GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19106
Status
Study Complete
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GSK Investigational Site
Savannah, Georgia, United States, 31405
Status
Study Complete
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GSK Investigational Site
Haysville, Kansas, United States, 67060
Status
Study Complete
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GSK Investigational Site
Endwell, New York, United States, 13760
Status
Recruiting
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GSK Investigational Site
Portland, Oregon, United States, 97210
Status
Study Complete
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GSK Investigational Site
Nashville, Tennessee, United States, 37205
Status
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GSK Investigational Site
Albuquerque, New Mexico, United States, 87106
Status
Study Complete
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GSK Investigational Site
Meridian, Idaho, United States, 83642
Status
Study Complete
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GSK Investigational Site
Melbourne, Florida, United States, 32901
Status
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GSK Investigational Site
Morton Grove, Illinois, United States, 61550
Status
Recruiting
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GSK Investigational Site
Kissimmee, Florida, United States, 34741
Status
Study Complete
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GSK Investigational Site
Oakbrook Terrace, Illinois, United States, 60181
Status
Study Complete
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GSK Investigational Site
Towson, Maryland, United States, 21204-7736
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GSK Investigational Site
Atlanta, Georgia, United States, 30339
Status
Study Complete
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GSK Investigational Site
Severna Park, Maryland, United States, 21146
Status
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GSK Investigational Site
Wheaton, Maryland, United States, 20906
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Study Complete
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GSK Investigational Site
Bristol, Tennessee, United States, 37620
Status
Study Complete
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GSK Investigational Site
Peoria, Illinois, United States, 61602
Status
Recruiting
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GSK Investigational Site
San Francisco, California, United States, 94122
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Recruiting
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GSK Investigational Site
Dunwoody, Georgia, United States, 30328
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GSK Investigational Site
Pittsford, New York, United States, 14534
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Recruiting
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GSK Investigational Site
Chesterfield, Missouri, United States, 63017
Status
Study Complete
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GSK Investigational Site
Burlington, Massachusetts, United States, 01805
Status
Study Complete
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GSK Investigational Site
Tulsa, Oklahoma, United States, 74135
Status
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GSK Investigational Site
Oakhurst, New Jersey, United States, 07755
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Study Complete
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GSK Investigational Site
Lafayette, Louisiana, United States, 70508
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GSK Investigational Site
Philadelphia, Pennsylvania, United States, 19148
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GSK Investigational Site
Centennial, Colorado, United States, 80112
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Study Complete
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GSK Investigational Site
Lexington, Kentucky, United States, 40536
Status
Will Be Recruiting
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Location
GSK Investigational Site
Garden Grove, California, United States, 92840
Status
Recruiting
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GSK Investigational Site
Atlanta, Georgia, United States, 30328
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GSK Investigational Site
Birmingham, Alabama, United States, 35235
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GSK Investigational Site
Sellersville, Pennsylvania, United States, 18960
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GSK Investigational Site
Lincoln, Nebraska, United States, 68503
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GSK Investigational Site
Cary, North Carolina, United States, 27511
Status
Study Complete
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GSK Investigational Site
Greensboro, North Carolina, United States, 27403
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Recruiting
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GSK Investigational Site
Lexington, Kentucky, United States, 40508
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Recruiting
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GSK Investigational Site
Weber City, Virginia, United States, 24290
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Study Complete
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GSK Investigational Site
Johnson City, Tennessee, United States, 37601
Status
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Location
GSK Investigational Site
Torrance, California, United States, 90505
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GSK Investigational Site
Belleair Bluffs, Florida, United States, 33770
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GSK Investigational Site
Winston-Salem, North Carolina, United States, 27103
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GSK Investigational Site
Salt Lake City, Utah, United States, 84132
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GSK Investigational Site
Charleston, South Carolina, United States, 29407
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GSK Investigational Site
Berlin, New Jersey, United States, 08009
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GSK Investigational Site
Omaha, Nebraska, United States, 68144
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GSK Investigational Site
New Orleans, Louisiana, United States, 70128
Status
Study Complete
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GSK Investigational Site
Christiansburg, Virginia, United States, 24073
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GSK Investigational Site
Encinitas, California, United States, 92024
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Study Complete
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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
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GSK Investigational Site
Columbus, Ohio, United States, 43215
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Study Complete
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Location
GSK Investigational Site
Indianapolis, Indiana, United States, 46237
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GSK Investigational Site
Portland, Oregon, United States, 97225
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Study documents

Scientific result summary
Available language(s): English
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If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
Completed
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
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