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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| alosetron | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Birmingham | Alabama | 35235 | United States | ||
| GSK Investigational Site |
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| Birmingham |
| Alabama |
| 35242 |
| United States |
| GSK Investigational Site | Huntsville | Alabama | 35801 | United States |
| GSK Investigational Site | Mobile | Alabama | 36693 | United States |
| GSK Investigational Site | Pell City | Alabama | 35125 | United States |
| GSK Investigational Site | Tallassee | Alabama | 36078 | United States |
| GSK Investigational Site | Tucson | Arizona | 85712 | United States |
| GSK Investigational Site | Little Rock | Arkansas | 72205 | United States |
| GSK Investigational Site | North Little Rock | Arkansas | 72117 | United States |
| GSK Investigational Site | Beverly Hills | California | 90211 | United States |
| GSK Investigational Site | Carlsbad | California | 92008 | United States |
| GSK Investigational Site | Concord | California | 94520 | United States |
| GSK Investigational Site | Encinitas | California | 92024 | United States |
| GSK Investigational Site | Fresno | California | 93720 | United States |
| GSK Investigational Site | Garden Grove | California | 92840 | United States |
| GSK Investigational Site | Los Angeles | California | 90035 | United States |
| GSK Investigational Site | Orange | California | 92868 | United States |
| GSK Investigational Site | Roseville | California | 95661 | United States |
| GSK Investigational Site | San Diego | California | 92103 | United States |
| GSK Investigational Site | San Diego | California | 92108 | United States |
| GSK Investigational Site | San Diego | California | 92120 | United States |
| GSK Investigational Site | San Francisco | California | 94114 | United States |
| GSK Investigational Site | San Francisco | California | 94115 | United States |
| GSK Investigational Site | San Francisco | California | 94122 | United States |
| GSK Investigational Site | Santa Ana | California | 92704 | United States |
| GSK Investigational Site | Spring Valley | California | 91978 | United States |
| GSK Investigational Site | Torrance | California | 90505 | United States |
| GSK Investigational Site | Van Nuys | California | 91405 | United States |
| GSK Investigational Site | Centennial | Colorado | 80112 | United States |
| GSK Investigational Site | Colorado Springs | Colorado | 80909 | United States |
| GSK Investigational Site | Littleton | Colorado | 80120 | United States |
| GSK Investigational Site | Longmont | Colorado | 80501 | United States |
| GSK Investigational Site | Bristol | Connecticut | 06010 | United States |
| GSK Investigational Site | Belleair Bluffs | Florida | 33770 | United States |
| GSK Investigational Site | Boca Raton | Florida | 33428 | United States |
| GSK Investigational Site | Bradenton | Florida | 34209 | United States |
| GSK Investigational Site | Clearwater | Florida | 33756 | United States |
| GSK Investigational Site | Clearwater | Florida | 33765 | United States |
| GSK Investigational Site | DeLand | Florida | 32720 | United States |
| GSK Investigational Site | Gainesville | Florida | 32607 | United States |
| GSK Investigational Site | Hollywood | Florida | 33021 | United States |
| GSK Investigational Site | Jacksonville | Florida | 32209 | United States |
| GSK Investigational Site | Jacksonville | Florida | 32256-6004 | United States |
| GSK Investigational Site | Kissimmee | Florida | 34741 | United States |
| GSK Investigational Site | Melbourne | Florida | 32901 | United States |
| GSK Investigational Site | North Miami Beach | Florida | 33162 | United States |
| GSK Investigational Site | Spring Hill | Florida | 34608 | United States |
| GSK Investigational Site | Stuart | Florida | 34996 | United States |
| GSK Investigational Site | Zephyrhills | Florida | 33540 | United States |
| GSK Investigational Site | Atlanta | Georgia | 30328 | United States |
| GSK Investigational Site | Atlanta | Georgia | 30339 | United States |
| GSK Investigational Site | Blue Ridge | Georgia | 30513 | United States |
| GSK Investigational Site | Dunwoody | Georgia | 30328 | United States |
| GSK Investigational Site | Fayetteville | Georgia | 30214 | United States |
| GSK Investigational Site | Rome | Georgia | 30165 | United States |
| GSK Investigational Site | Savannah | Georgia | 31405 | United States |
| GSK Investigational Site | Boise | Idaho | 83702 | United States |
| GSK Investigational Site | Coeur d'Alene | Idaho | 83814 | United States |
| GSK Investigational Site | Meridian | Idaho | 83642 | United States |
| GSK Investigational Site | Chicago | Illinois | 60612-7323 | United States |
| GSK Investigational Site | Chicago | Illinois | 60637 | United States |
| GSK Investigational Site | Libertyville | Illinois | 60048 | United States |
| GSK Investigational Site | Moline | Illinois | 61265 | United States |
| GSK Investigational Site | Morton Grove | Illinois | 61550 | United States |
| GSK Investigational Site | Oakbrook Terrace | Illinois | 60181 | United States |
| GSK Investigational Site | Peoria | Illinois | 61602 | United States |
| GSK Investigational Site | Rockford | Illinois | 61107 | United States |
| GSK Investigational Site | Indianapolis | Indiana | 46208 | United States |
| GSK Investigational Site | Indianapolis | Indiana | 46237 | United States |
| GSK Investigational Site | Jeffersonville | Indiana | 47130 | United States |
| GSK Investigational Site | Clive | Iowa | 50325 | United States |
| GSK Investigational Site | Haysville | Kansas | 67060 | United States |
| GSK Investigational Site | Kansas City | Kansas | 66160 | United States |
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| GSK Investigational Site | Shreveport | Louisiana | 71103 | United States |
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| GSK Investigational Site | Baltimore | Maryland | 21215 | United States |
| GSK Investigational Site | Baltimore | Maryland | 21229 | United States |
| GSK Investigational Site | Lanham | Maryland | 20706 | United States |
| GSK Investigational Site | Oxon Hill | Maryland | 20745 | United States |
| GSK Investigational Site | Severna Park | Maryland | 21146 | United States |
| GSK Investigational Site | Silver Spring | Maryland | 20910 | United States |
| GSK Investigational Site | Towson | Maryland | 21204-7736 | United States |
| GSK Investigational Site | Towson | Maryland | 21204 | United States |
| GSK Investigational Site | Wheaton | Maryland | 20906 | United States |
| GSK Investigational Site | Burlington | Massachusetts | 01805 | United States |
| GSK Investigational Site | Farmington Hills | Michigan | 48334 | United States |
| GSK Investigational Site | Northville | Michigan | 48167 | United States |
| GSK Investigational Site | Petoskey | Michigan | 49770 | United States |
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| GSK Investigational Site | Brooklyn Center | Minnesota | 55430 | United States |
| GSK Investigational Site | Chesterfield | Missouri | 63017 | United States |
| GSK Investigational Site | St Louis | Missouri | 63141 | United States |
| GSK Investigational Site | Lincoln | Nebraska | 68503 | United States |
| GSK Investigational Site | Omaha | Nebraska | 68144 | United States |
| GSK Investigational Site | Las Vegas | Nevada | 89119 | United States |
| GSK Investigational Site | Berlin | New Jersey | 08009 | United States |
| GSK Investigational Site | Blackwood | New Jersey | 08012 | United States |
| GSK Investigational Site | Cedar Knolls | New Jersey | 7927 | United States |
| GSK Investigational Site | Oakhurst | New Jersey | 07755 | United States |
| GSK Investigational Site | Passaic | New Jersey | 07055 | United States |
| GSK Investigational Site | South Bound Brook | New Jersey | 08880 | United States |
| GSK Investigational Site | Willingboro | New Jersey | 08046 | United States |
| GSK Investigational Site | Albuquerque | New Mexico | 87106 | United States |
| GSK Investigational Site | Albany | New York | 12205 | United States |
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| GSK Investigational Site | Endwell | New York | 13760 | United States |
| GSK Investigational Site | Great Neck | New York | 11023 | United States |
| GSK Investigational Site | Pittsford | New York | 14534 | United States |
| GSK Investigational Site | Pomona | New York | 10970 | United States |
| GSK Investigational Site | Cary | North Carolina | 27511 | United States |
| GSK Investigational Site | Charlotte | North Carolina | 28262 | United States |
| GSK Investigational Site | Gastonia | North Carolina | 28054 | United States |
| GSK Investigational Site | Greensboro | North Carolina | 27403 | United States |
| GSK Investigational Site | Greenville | North Carolina | 27858 | United States |
| GSK Investigational Site | Jacksonville | North Carolina | 28546 | United States |
| GSK Investigational Site | Raleigh | North Carolina | 27609 | United States |
| GSK Investigational Site | Wilmington | North Carolina | 28401 | United States |
| GSK Investigational Site | Wilmington | North Carolina | 28412 | United States |
| GSK Investigational Site | Winston-Salem | North Carolina | 27103 | United States |
| GSK Investigational Site | Bellbrook | Ohio | 45305 | United States |
| GSK Investigational Site | Cincinnati | Ohio | 45236 | United States |
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| GSK Investigational Site | Wandsworth | Ohio | 44281 | United States |
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| GSK Investigational Site | Tulsa | Oklahoma | 74135 | United States |
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| GSK Investigational Site | Portland | Oregon | 97225 | United States |
| GSK Investigational Site | Bensalem | Pennsylvania | 19020 | United States |
| GSK Investigational Site | Duncansville | Pennsylvania | 16635 | United States |
| GSK Investigational Site | Feasterville | Pennsylvania | 19053 | United States |
| GSK Investigational Site | Levittown | Pennsylvania | 19057 | United States |
| GSK Investigational Site | Media | Pennsylvania | 19063 | United States |
| GSK Investigational Site | Morrisville | Pennsylvania | 19067 | United States |
| GSK Investigational Site | Penndel | Pennsylvania | 19047 | United States |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19106 | United States |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19107 | United States |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19148 | United States |
| GSK Investigational Site | Pittsburgh | Pennsylvania | 15218 | United States |
| GSK Investigational Site | Reading | Pennsylvania | 19611 | United States |
| GSK Investigational Site | Sellersville | Pennsylvania | 18960 | United States |
| GSK Investigational Site | Stoneboro | Pennsylvania | 16153 | United States |
| GSK Investigational Site | Anderson | South Carolina | 29621 | United States |
| GSK Investigational Site | Charleston | South Carolina | 29407 | United States |
| GSK Investigational Site | Summerville | South Carolina | 29485 | United States |
| GSK Investigational Site | Sioux Falls | South Dakota | 57105 | United States |
| GSK Investigational Site | Bristol | Tennessee | 37620 | United States |
| GSK Investigational Site | Clarksville | Tennessee | 37043 | United States |
| GSK Investigational Site | Jackson | Tennessee | 38305 | United States |
| GSK Investigational Site | Johnson City | Tennessee | 37601 | United States |
| GSK Investigational Site | Kingsport | Tennessee | 37660 | United States |
| GSK Investigational Site | Knoxville | Tennessee | 37920 | United States |
| GSK Investigational Site | Memphis | Tennessee | 38119 | United States |
| GSK Investigational Site | Nashville | Tennessee | 37205 | United States |
| GSK Investigational Site | Austin | Texas | 78758 | United States |
| GSK Investigational Site | Conroe | Texas | 77304 | United States |
| GSK Investigational Site | Dallas | Texas | 75230 | United States |
| GSK Investigational Site | Houston | Texas | 77024 | United States |
| GSK Investigational Site | Humble | Texas | 77338 | United States |
| GSK Investigational Site | North Richland Hills | Texas | 76180 | United States |
| GSK Investigational Site | Pasadena | Texas | 77505 | United States |
| GSK Investigational Site | San Antonio | Texas | 78205 | United States |
| GSK Investigational Site | San Antonio | Texas | 78229 | United States |
| GSK Investigational Site | Sugar Land | Texas | 77478 | United States |
| GSK Investigational Site | The Woodlands | Texas | 77381 | United States |
| GSK Investigational Site | Salt Lake City | Utah | 84132 | United States |
| GSK Investigational Site | Chesapeake | Virginia | 23320 | United States |
| GSK Investigational Site | Christiansburg | Virginia | 24073 | United States |
| GSK Investigational Site | Danville | Virginia | 24541 | United States |
| GSK Investigational Site | Norfolk | Virginia | 23502 | United States |
| GSK Investigational Site | Norfolk | Virginia | 23507 | United States |
| GSK Investigational Site | Richmond | Virginia | 23294 | United States |
| GSK Investigational Site | Virginia Beach | Virginia | 23455 | United States |
| GSK Investigational Site | Weber City | Virginia | 24290 | United States |
| GSK Investigational Site | Bellevue | Washington | 98004 | United States |
| GSK Investigational Site | Gig Harbor | Washington | 98335 | United States |
| GSK Investigational Site | Lacey | Washington | 98516 | United States |
| GSK Investigational Site | Tacoma | Washington | 98405 | United States |
| GSK Investigational Site | La Crosse | Wisconsin | 54601 | United States |
| GSK Investigational Site | Madison | Wisconsin | 53792 | United States |
| GSK Investigational Site | Nedlands | Western Australia | 27408 | Australia |
| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C090840 | alosetron |
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