Irritable Bowel Syndrome (IBS) Clinical Trial
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
| 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 as needed versus fixed dosing of an investigational medication for women with severe diarrhea-predominant Irritable Bowel Syndrome (IBS) who have failed conventional therapy.
| Status | Completed |
| Enrollment | 700 |
| Est. completion date | December 2005 |
| Est. primary completion date | December 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 | Albany | New York |
| United States | GSK Investigational Site | Albuquerque | New Mexico |
| United States | GSK Investigational Site | Anderson | South Carolina |
| United States | GSK Investigational Site | Annapolis | Maryland |
| United States | GSK Investigational Site | Atlanta | Georgia |
| United States | GSK Investigational Site | Atlanta | Georgia |
| United States | GSK Investigational Site | Austin | Texas |
| United States | GSK Investigational Site | Baltimore | Maryland |
| United States | GSK Investigational Site | Baltimore | Maryland |
| United States | GSK Investigational Site | Bellbrook | Ohio |
| United States | GSK Investigational Site | Belleair Bluffs | Florida |
| United States | GSK Investigational Site | Bellevue | Washington |
| United States | GSK Investigational Site | Bensalem | Pennsylvania |
| United States | GSK Investigational Site | Berlin | New Jersey |
| United States | GSK Investigational Site | Beverly Hills | California |
| United States | GSK Investigational Site | Binghamton | New York |
| United States | GSK Investigational Site | Birmingham | Alabama |
| United States | GSK Investigational Site | Birmingham | Alabama |
| United States | GSK Investigational Site | Blackwood | New Jersey |
| United States | GSK Investigational Site | Blue Ridge | Georgia |
| United States | GSK Investigational Site | Boca Raton | Florida |
| United States | GSK Investigational Site | Boise | Idaho |
| United States | GSK Investigational Site | Bradenton | Florida |
| United States | GSK Investigational Site | Bristol | Connecticut |
| United States | GSK Investigational Site | Bristol | Tennessee |
| United States | GSK Investigational Site | Brooklyn Center | Minnesota |
| United States | GSK Investigational Site | Burlington | Massachusetts |
| United States | GSK Investigational Site | Carlsbad | California |
| United States | GSK Investigational Site | Cary | North Carolina |
| United States | GSK Investigational Site | Cedar Knolls | New Jersey |
| United States | GSK Investigational Site | Centennial | Colorado |
| United States | GSK Investigational Site | Charleston | South Carolina |
| United States | GSK Investigational Site | Charlotte | North Carolina |
| United States | GSK Investigational Site | Chesapeake | Virginia |
| United States | GSK Investigational Site | Chesterfield | Missouri |
| United States | GSK Investigational Site | Chicago | Illinois |
| United States | GSK Investigational Site | Chicago | Illinois |
| United States | GSK Investigational Site | Christiansburg | Virginia |
| United States | GSK Investigational Site | Cincinnati | Ohio |
| United States | GSK Investigational Site | Clarksville | Tennessee |
| United States | GSK Investigational Site | Clearwater | Florida |
| United States | GSK Investigational Site | Clearwater | Florida |
| United States | GSK Investigational Site | Clive | Iowa |
| United States | GSK Investigational Site | Coeur D'Alene | Idaho |
| United States | GSK Investigational Site | Colorado Springs | Colorado |
| United States | GSK Investigational Site | Columbus | Ohio |
| United States | GSK Investigational Site | Columbus | Ohio |
| United States | GSK Investigational Site | Concord | California |
| United States | GSK Investigational Site | Conroe | Texas |
| United States | GSK Investigational Site | Covington | Louisiana |
| United States | GSK Investigational Site | Dallas | Texas |
| United States | GSK Investigational Site | Danville | Virginia |
| United States | GSK Investigational Site | Deland | Florida |
| United States | GSK Investigational Site | Duncansville | Pennsylvania |
| United States | GSK Investigational Site | Dunwoody | Georgia |
| United States | GSK Investigational Site | Encinitas | California |
| United States | GSK Investigational Site | Endwell | New York |
| United States | GSK Investigational Site | Farmington Hills | Michigan |
| United States | GSK Investigational Site | Fayetteville | Georgia |
| United States | GSK Investigational Site | Feasterville | Pennsylvania |
| United States | GSK Investigational Site | Florence | Kentucky |
| United States | GSK Investigational Site | Fresno | California |
| United States | GSK Investigational Site | Gainesville | Florida |
| United States | GSK Investigational Site | Garden Grove | California |
| United States | GSK Investigational Site | Gastonia | North Carolina |
| United States | GSK Investigational Site | Gig Harbor | Washington |
| United States | GSK Investigational Site | Great Neck | New York |
| United States | GSK Investigational Site | Greensboro | North Carolina |
| United States | GSK Investigational Site | Greenville | North Carolina |
| United States | GSK Investigational Site | Haysville | Kansas |
| United States | GSK Investigational Site | Hollywood | Florida |
| United States | GSK Investigational Site | Houston | Texas |
| United States | GSK Investigational Site | Humble | Texas |
| United States | GSK Investigational Site | Huntsville | Alabama |
| United States | GSK Investigational Site | Indianapolis | Indiana |
| United States | GSK Investigational Site | Indianapolis | Indiana |
| United States | GSK Investigational Site | Jackson | Tennessee |
| United States | GSK Investigational Site | Jacksonville | North Carolina |
| United States | GSK Investigational Site | Jacksonville | Florida |
| United States | GSK Investigational Site | Jacksonville | Florida |
| United States | GSK Investigational Site | Jeffersonville | Indiana |
| United States | GSK Investigational Site | Johnson City | Tennessee |
| United States | GSK Investigational Site | Kansas City | Kansas |
| United States | GSK Investigational Site | Kingsport | Tennessee |
| United States | GSK Investigational Site | Kissimmee | Florida |
| United States | GSK Investigational Site | Knoxville | Tennessee |
| United States | GSK Investigational Site | La Crosse | Wisconsin |
| United States | GSK Investigational Site | Lacey | Washington |
| United States | GSK Investigational Site | Lafayette | Louisiana |
| United States | GSK Investigational Site | Lanham | Maryland |
| United States | GSK Investigational Site | Las Vegas | Nevada |
| United States | GSK Investigational Site | Levittown | Pennsylvania |
| United States | GSK Investigational Site | Lexington | Kentucky |
| United States | GSK Investigational Site | Lexington | Kentucky |
| United States | GSK Investigational Site | Libertyville | Illinois |
| United States | GSK Investigational Site | Lincoln | Nebraska |
| United States | GSK Investigational Site | Little Rock | Arkansas |
| United States | GSK Investigational Site | Littleton | Colorado |
| United States | GSK Investigational Site | Longmont | Colorado |
| United States | GSK Investigational Site | Los Angeles | California |
| United States | GSK Investigational Site | Madison | Wisconsin |
| United States | GSK Investigational Site | Madisonville | Kentucky |
| United States | GSK Investigational Site | Media | Pennsylvania |
| United States | GSK Investigational Site | Melbourne | Florida |
| United States | GSK Investigational Site | Memphis | Tennessee |
| United States | GSK Investigational Site | Meridian | Idaho |
| United States | GSK Investigational Site | Mobile | Alabama |
| United States | GSK Investigational Site | Moline | Illinois |
| United States | GSK Investigational Site | Monroe | Louisiana |
| United States | GSK Investigational Site | Morrisville | Pennsylvania |
| United States | GSK Investigational Site | Morton Grove | Illinois |
| United States | GSK Investigational Site | Nashville | Tennessee |
| United States | GSK Investigational Site | New Orleans | Louisiana |
| United States | GSK Investigational Site | New Orleans | Louisiana |
| United States | GSK Investigational Site | Norfolk | Virginia |
| United States | GSK Investigational Site | Norfolk | Virginia |
| United States | GSK Investigational Site | North Little Rock | Arkansas |
| United States | GSK Investigational Site | North Miami Beach | Florida |
| United States | GSK Investigational Site | North Richland Hills | Texas |
| United States | GSK Investigational Site | Northville | Michigan |
| United States | GSK Investigational Site | Oakbrook Terrace | Illinois |
| United States | GSK Investigational Site | Oakhurst | New Jersey |
| United States | GSK Investigational Site | Oklahoma City | Oklahoma |
| United States | GSK Investigational Site | Omaha | Nebraska |
| United States | GSK Investigational Site | Orange | California |
| United States | GSK Investigational Site | Oxon Hill | Maryland |
| United States | GSK Investigational Site | Pasadena | Texas |
| United States | GSK Investigational Site | Passaic | New Jersey |
| United States | GSK Investigational Site | Pell City | Alabama |
| United States | GSK Investigational Site | Penndel | Pennsylvania |
| United States | GSK Investigational Site | Peoria | Illinois |
| United States | GSK Investigational Site | Petoskey | Michigan |
| United States | GSK Investigational Site | Philadelphia | Pennsylvania |
| United States | GSK Investigational Site | Philadelphia | Pennsylvania |
| United States | GSK Investigational Site | Philadelphia | Pennsylvania |
| United States | GSK Investigational Site | Pittsburgh | Pennsylvania |
| United States | GSK Investigational Site | Pittsford | New York |
| United States | GSK Investigational Site | Pomona | New York |
| United States | GSK Investigational Site | Portland | Oregon |
| United States | GSK Investigational Site | Portland | Oregon |
| United States | GSK Investigational Site | Raleigh | North Carolina |
| United States | GSK Investigational Site | Reading | Pennsylvania |
| United States | GSK Investigational Site | Richmond | Virginia |
| United States | GSK Investigational Site | Rockford | Illinois |
| United States | GSK Investigational Site | Rome | Georgia |
| United States | GSK Investigational Site | Roseville | California |
| United States | GSK Investigational Site | Saginaw | Michigan |
| United States | GSK Investigational Site | Salt Lake City | Utah |
| 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 Diego | California |
| United States | GSK Investigational Site | San Francisco | California |
| United States | GSK Investigational Site | San Francisco | California |
| United States | GSK Investigational Site | San Francisco | California |
| United States | GSK Investigational Site | Santa Ana | California |
| United States | GSK Investigational Site | Savannah | Georgia |
| United States | GSK Investigational Site | Sellersville | Pennsylvania |
| United States | GSK Investigational Site | Severna Park | Maryland |
| United States | GSK Investigational Site | Shreveport | Louisiana |
| United States | GSK Investigational Site | Silver Spring | Maryland |
| United States | GSK Investigational Site | Sioux Falls | South Dakota |
| United States | GSK Investigational Site | South Bound Brook | New Jersey |
| United States | GSK Investigational Site | Spring Hill | Florida |
| United States | GSK Investigational Site | Spring Valley | California |
| United States | GSK Investigational Site | St. Louis | Missouri |
| United States | GSK Investigational Site | Stoneboro | Pennsylvania |
| United States | GSK Investigational Site | Stuart | Florida |
| United States | GSK Investigational Site | Sugar Land | Texas |
| United States | GSK Investigational Site | Summerville | South Carolina |
| United States | GSK Investigational Site | Tacoma | Washington |
| United States | GSK Investigational Site | Tallassee | Alabama |
| United States | GSK Investigational Site | Torrance | California |
| United States | GSK Investigational Site | Towson | Maryland |
| 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 | Van Nuys | California |
| United States | GSK Investigational Site | Virginia Beach | Virginia |
| United States | GSK Investigational Site | Wandsworth | Ohio |
| United States | GSK Investigational Site | Weber City | Virginia |
| United States | GSK Investigational Site | Wheaton | Maryland |
| United States | GSK Investigational Site | Wichita | Kansas |
| United States | GSK Investigational Site | Willingboro | New Jersey |
| United States | GSK Investigational Site | Wilmington | North Carolina |
| United States | GSK Investigational Site | Wilmington | North Carolina |
| United States | GSK Investigational Site | Winston-Salem | North Carolina |
| United States | GSK Investigational Site | Woodlands | Texas |
| 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. | 12 Weeks | ||
| Secondary | 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. | 12 Weeks |
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