Irritable Bowel Syndrome (IBS) Clinical Trial
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
| Verified date | April 2015 |
| Source | GlaxoSmithKline |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 702 |
| Est. completion date | January 2005 |
| Est. primary completion date | January 2005 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Australia | GSK Investigational Site | Nedlands | Western Australia |
| United States | GSK Investigational Site | Akron | Ohio |
| United States | GSK Investigational Site | Alexandria | Virginia |
| United States | GSK Investigational Site | Altoona | Pennsylvania |
| United States | GSK Investigational Site | Ann Arbor | Michigan |
| United States | GSK Investigational Site | Arlington | Texas |
| United States | GSK Investigational Site | Asheville | North Carolina |
| United States | GSK Investigational Site | Atlanta | Georgia |
| United States | GSK Investigational Site | Atlanta | Georgia |
| United States | GSK Investigational Site | Atlanta | Georgia |
| United States | GSK Investigational Site | Attleboro | Massachusetts |
| United States | GSK Investigational Site | Austell | Georgia |
| United States | GSK Investigational Site | Austin | Texas |
| United States | GSK Investigational Site | Baltimore | Maryland |
| United States | GSK Investigational Site | Bayshore | New York |
| United States | GSK Investigational Site | Beavercreek | Ohio |
| United States | GSK Investigational Site | Birmingham | Alabama |
| United States | GSK Investigational Site | Bismarck | North Dakota |
| United States | GSK Investigational Site | Bloomfield | New Jersey |
| United States | GSK Investigational Site | Boca Raton | Florida |
| United States | GSK Investigational Site | Boston | Massachusetts |
| United States | GSK Investigational Site | Boston | Massachusetts |
| United States | GSK Investigational Site | Boulder | Colorado |
| United States | GSK Investigational Site | Bountiful | Utah |
| United States | GSK Investigational Site | Bowling Green | Kentucky |
| United States | GSK Investigational Site | Boynton Beach | Florida |
| United States | GSK Investigational Site | Boynton Beach | Florida |
| United States | GSK Investigational Site | Bristol | Tennessee |
| United States | GSK Investigational Site | Calera | Alabama |
| United States | GSK Investigational Site | Cary | North Carolina |
| United States | GSK Investigational Site | Chapel Hill | North Carolina |
| United States | GSK Investigational Site | Charlotte | North Carolina |
| United States | GSK Investigational Site | Charlottesville | Virginia |
| United States | GSK Investigational Site | Charlottesville | Virginia |
| United States | GSK Investigational Site | Chaska | Minnesota |
| United States | GSK Investigational Site | Chesapeake | Virginia |
| United States | GSK Investigational Site | Chula Vista | California |
| United States | GSK Investigational Site | Cincinnati | Ohio |
| United States | GSK Investigational Site | Cincinnati | Ohio |
| United States | GSK Investigational Site | Cincinnati | Ohio |
| United States | GSK Investigational Site | Cleveland | Ohio |
| United States | GSK Investigational Site | Cleveland | Ohio |
| United States | GSK Investigational Site | Colorado Springs | Colorado |
| United States | GSK Investigational Site | Colorado Springs | Colorado |
| United States | GSK Investigational Site | Columbia | South Carolina |
| United States | GSK Investigational Site | Columbus | Ohio |
| United States | GSK Investigational Site | Coral Gables | Florida |
| United States | GSK Investigational Site | Corpus Christi | Texas |
| United States | GSK Investigational Site | Dallas | Texas |
| United States | GSK Investigational Site | Davenport | Louisiana |
| United States | GSK Investigational Site | Dayton | Ohio |
| United States | GSK Investigational Site | Decatur | Georgia |
| United States | GSK Investigational Site | Detroit | Michigan |
| United States | GSK Investigational Site | East Providence | Rhode Island |
| United States | GSK Investigational Site | Egg Harbor Township | New Jersey |
| United States | GSK Investigational Site | Englewood | Colorado |
| United States | GSK Investigational Site | Farmington | New Mexico |
| United States | GSK Investigational Site | Fayetteville | North Carolina |
| United States | GSK Investigational Site | Fayetteville | Arkansas |
| United States | GSK Investigational Site | Fleetwood | Pennsylvania |
| United States | GSK Investigational Site | Fort Myers | Florida |
| United States | GSK Investigational Site | Fort Myers | Florida |
| United States | GSK Investigational Site | Fountain Valley | California |
| United States | GSK Investigational Site | Garden Grove | California |
| United States | GSK Investigational Site | Grand Rapids | Michigan |
| United States | GSK Investigational Site | Great Neck | New York |
| United States | GSK Investigational Site | Greenville | North Carolina |
| United States | GSK Investigational Site | Greenville | South Carolina |
| United States | GSK Investigational Site | Hershey | Pennsylvania |
| United States | GSK Investigational Site | Hialeah | Florida |
| United States | GSK Investigational Site | Hickory | North Carolina |
| United States | GSK Investigational Site | High Point | North Carolina |
| United States | GSK Investigational Site | Hollywood | Florida |
| United States | GSK Investigational Site | Houston | Texas |
| United States | GSK Investigational Site | Houston | Texas |
| United States | GSK Investigational Site | Houston | Texas |
| United States | GSK Investigational Site | Humble | Texas |
| United States | GSK Investigational Site | Indianapolis | Indiana |
| United States | GSK Investigational Site | Indianapolis | Indiana |
| United States | GSK Investigational Site | Irving | Texas |
| United States | GSK Investigational Site | Jackson | Mississippi |
| United States | GSK Investigational Site | Jefferson City | Missouri |
| United States | GSK Investigational Site | Jefferson City | Missouri |
| United States | GSK Investigational Site | Kansas City | Missouri |
| United States | GSK Investigational Site | Kettering | Ohio |
| United States | GSK Investigational Site | Kingsport | Tennessee |
| United States | GSK Investigational Site | Lacey | Washington |
| United States | GSK Investigational Site | Lake Worth | Florida |
| United States | GSK Investigational Site | Lancaster | California |
| United States | GSK Investigational Site | Lancaster | Pennsylvania |
| United States | GSK Investigational Site | Laurel | Maryland |
| United States | GSK Investigational Site | Lebanon | New Hampshire |
| United States | GSK Investigational Site | Longwood | Florida |
| United States | GSK Investigational Site | Los Angeles | California |
| United States | GSK Investigational Site | Louisville | Kentucky |
| United States | GSK Investigational Site | Louisville | Kentucky |
| United States | GSK Investigational Site | Lyndhurst | Ohio |
| United States | GSK Investigational Site | Madisonville | Kentucky |
| United States | GSK Investigational Site | Manchester | Connecticut |
| United States | GSK Investigational Site | Marietta | Georgia |
| United States | GSK Investigational Site | Martinez | Georgia |
| United States | GSK Investigational Site | Medford | Oregon |
| United States | GSK Investigational Site | Memphis | Tennessee |
| United States | GSK Investigational Site | Memphis | Tennessee |
| United States | GSK Investigational Site | Merrick | New York |
| United States | GSK Investigational Site | Miami | Florida |
| United States | GSK Investigational Site | Miami | Florida |
| United States | GSK Investigational Site | Milwaukee | Wisconsin |
| United States | GSK Investigational Site | Milwaukee | Wisconsin |
| United States | GSK Investigational Site | Milwaukee | Wisconsin |
| United States | GSK Investigational Site | Milwaukee | Wisconsin |
| United States | GSK Investigational Site | Missoula | Montana |
| United States | GSK Investigational Site | Morehead City | North Carolina |
| United States | GSK Investigational Site | Murfreesboro | Tennessee |
| United States | GSK Investigational Site | Naples | Florida |
| United States | GSK Investigational Site | Nashville | Tennessee |
| United States | GSK Investigational Site | New Port Richey | Florida |
| United States | GSK Investigational Site | Newport Beach | California |
| United States | GSK Investigational Site | Newtown | Pennsylvania |
| United States | GSK Investigational Site | Oak Park | Michigan |
| United States | GSK Investigational Site | Ocala | Florida |
| United States | GSK Investigational Site | Ocean | New Jersey |
| United States | GSK Investigational Site | Ogden | Utah |
| United States | GSK Investigational Site | Oklahoma City | Oklahoma |
| United States | GSK Investigational Site | Oklahoma City | Oklahoma |
| United States | GSK Investigational Site | Overland Park | Kansas |
| United States | GSK Investigational Site | Panama City | Florida |
| United States | GSK Investigational Site | Peoria | Illinois |
| United States | GSK Investigational Site | Phoenix | Arizona |
| United States | GSK Investigational Site | Pittsburgh | Pennsylvania |
| United States | GSK Investigational Site | Raleigh | North Carolina |
| United States | GSK Investigational Site | Rancho Cucamonga | California |
| United States | GSK Investigational Site | Redlands | California |
| United States | GSK Investigational Site | Riverside | Illinois |
| United States | GSK Investigational Site | Rochester | New York |
| United States | GSK Investigational Site | San Antonio | Texas |
| United States | GSK Investigational Site | San Antonio | Texas |
| United States | GSK Investigational Site | San Diego | California |
| United States | GSK Investigational Site | San Diego | California |
| United States | GSK Investigational Site | San Rafael | California |
| United States | GSK Investigational Site | Santa Ana | California |
| United States | GSK Investigational Site | Santa Ana | California |
| United States | GSK Investigational Site | Sarasota | Florida |
| United States | GSK Investigational Site | Savannah | Georgia |
| United States | GSK Investigational Site | Silver Spring | Maryland |
| United States | GSK Investigational Site | Silver Spring | Maryland |
| United States | GSK Investigational Site | Simpsonville | South Carolina |
| United States | GSK Investigational Site | South Bend | Indiana |
| United States | GSK Investigational Site | Spokane | Washington |
| United States | GSK Investigational Site | St. Joseph | Michigan |
| United States | GSK Investigational Site | St. Paul | Minnesota |
| United States | GSK Investigational Site | St. Petersburg | Florida |
| United States | GSK Investigational Site | Stony Brook | New York |
| United States | GSK Investigational Site | Sugar Land | Texas |
| United States | GSK Investigational Site | Syracuse | New York |
| United States | GSK Investigational Site | Tallahassee | Florida |
| United States | GSK Investigational Site | Tampa | Florida |
| United States | GSK Investigational Site | Tomball | Texas |
| United States | GSK Investigational Site | Towson | Maryland |
| United States | GSK Investigational Site | Tucson | Arizona |
| United States | GSK Investigational Site | Tulsa | Oklahoma |
| United States | GSK Investigational Site | Tuscaloosa | Alabama |
| United States | GSK Investigational Site | Upland | California |
| United States | GSK Investigational Site | Vineland | New Jersey |
| United States | GSK Investigational Site | Vista | California |
| United States | GSK Investigational Site | Walla Walla | Washington |
| United States | GSK Investigational Site | Warren | Michigan |
| United States | GSK Investigational Site | Wenatchee | Washington |
| United States | GSK Investigational Site | Wentzville | Minnesota |
| United States | GSK Investigational Site | West Caldwell | New Jersey |
| United States | GSK Investigational Site | West Jordan | Utah |
| United States | GSK Investigational Site | West Palm Beach | Florida |
| United States | GSK Investigational Site | Wheat Ridge | Colorado |
| United States | GSK Investigational Site | Winston-Salem | North Carolina |
| United States | GSK Investigational Site | Wyomissing | Pennsylvania |
| United States | GSK Investigational Site | Yakima | Washington |
| United States | GSK Investigational Site | Yuba City | California |
| United States | GSK Investigational Site | Zephyrhills | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| GlaxoSmithKline |
United States, Australia,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | |||
| Secondary | Comparison of treatment groups with respect to subject relief of IBS pain & discomfort. |
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