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| Name | Class |
|---|---|
| RTI Health Solutions | OTHER |
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The purpose of this study is to evaluate the safety and efficacy of different doses of asimadoline in the treatment of patients with irritable bowel syndrome.
A randomized, dose-ranging, double-blind, placebo-controlled study designed to evaluate the efficacy and tolerability of three dose levels of asimadoline in subjects with IBS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| Asimadoline 0.15 mg | Experimental |
| |
| Asimadoline 0.5 mg | Experimental |
| |
| Asimadoline 1.0 mg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Asimadoline | Drug | Asimadoline was provided in coated tablets of three dosages (0.15 mg, 0.5 mg, and 1.0 mg). All asimadoline tablets used in this trial were synthesized from the same batch of drug substance (Batch EF418492). Asimadoline was administered orally, BID for 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Relief of IBS Pain - total months | The primary efficacy endpoint of the study was the total number of months with adequate relief of IBS pain or discomfort. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Relief of IBS Pain - percent of patients | Proportion of subjects with adequate relief of IBS pain or discomfort | 12 weeks |
| Relief of IBS Symptoms | Adequate relief of IBS symptoms |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Allen Mangel, MD, PhD | Tioga Pharmaceuticals | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Affiliated Research Center | Huntsville | Alabama | 35801 | United States | ||
| Lovelace Scientific Resources |
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|
|
| Placebo | Drug | Placebo was provided in coated tablets identical in appearance to asimadoline tablets. |
|
| 12 weeks |
| Lower GI function - change from baseline | Change from baseline in assessments of lower gastrointestinal (GI) function (i.e., stool frequency, stool consistency, urgency, bloating, and straining) | 12 weeks |
| Abdominal Pain Score - change from baseline | Change from baseline in abdominal pain score | 12 weeks |
| Abdominal Discomfort Score - change from baseline | Change from baseline in abdominal discomfort score | 12 weeks |
| Pheonix |
| Arizona |
| 85016 |
| United States |
| Lovelace Scientific Resources | Phoenix | Arizona | 85016 | United States |
| Redpoint Research | Phoenix | Arizona | 85029 | United States |
| Mayo Clinic Scottsdale - Division of Gastroenterology | Scottsdale | Arizona | 85259 | United States |
| Genova Clinical Research | Tucson | Arizona | 85741 | United States |
| Arkansas Gastroenterology | North Little Rock | Arkansas | 72117 | United States |
| Sutter Institute for Medical Research | Elk Grove | California | 95758 | United States |
| Digestive & Liver Disease Specialists | Garden Grove | California | 92840 | United States |
| Irvine Center for Clinical Research Inc. | Irvine | California | 92618 | United States |
| Community Clinical Trials | Orange | California | 92868 | United States |
| Sutter Institute for Medical Research | Sacramento | California | 95816 | United States |
| Nothern California Research | Sacramento | California | 95831 | United States |
| Westlake Medical Research | Westlake Village | California | 91361 | United States |
| Lynn Institute of the Rockies | Colorado Springs | Colorado | 80909 | United States |
| Longmont Medical Research Network | Longmont | Colorado | 80501 | United States |
| Western States Clinical Research Inc | Wheat Ridge | Colorado | 80033 | United States |
| Clinical Research Consultants, LLC | Stratford | Connecticut | 06615 | United States |
| Phoenix Internal Medicine Associates, LLC | Waterbury | Connecticut | 06708 | United States |
| Meridian Research | Brooksville | Florida | 34613 | United States |
| Florida Medical Research Institute | Gainesville | Florida | 32607 | United States |
| Research Consultants Group | Hialeah | Florida | 33010 | United States |
| Suncoast Clinical Research | New Port Richey | Florida | 34652 | United States |
| Universal Clinical Research & Technology | Orlando | Florida | 32833 | United States |
| Penninsula Research, Inc | Ormond Beach | Florida | 32174 | United States |
| Radiant Research - St. Petersburg | Pinellas Park | Florida | 33781 | United States |
| Lovelace Scientific Resources | Sarasota | Florida | 34233 | United States |
| Meridien Research | St. Petersburg | Florida | 33709 | United States |
| Meridien Research | Tampa | Florida | 33606 | United States |
| Michael S. Levine, MD | Marietta | Georgia | 30067 | United States |
| Mount Vernon Clinical Research | Sandy Springs | Georgia | 30318 | United States |
| Clinical Research Atlanta | Stockbridge | Georgia | 30281 | United States |
| Northwest Gastroenterologists S.C. | Arlington Heights | Illinois | 60005 | United States |
| Illinois Center for Clinical Research | Chicago | Illinois | 60622 | United States |
| University Digestive Health Center | Oak Forest | Illinois | 60452 | United States |
| BHS Digestive Disease Associates | Riverside | Illinois | 60546 | United States |
| Rockford Gastroenterology Associates Ltd | Rockford | Illinois | 61107 | United States |
| Indianapolis Gastroenterology Research Foundation | Indianapolis | Indiana | 46237 | United States |
| Heartland Medical Research, Inc | Clive | Iowa | 50325 | United States |
| Professional Research Network of Kansas | Wichita | Kansas | 67203 | United States |
| Heartland Research Associates, LLC | Wichita | Kansas | 67207 | United States |
| University of Louisville GI Research | Louisville | Kentucky | 40202 | United States |
| Commonwealth Biomedical Research, LLC | Madisonville | Kentucky | 42431 | United States |
| Digestive Health Center of Louisianna | Baton Rouge | Louisiana | 70809 | United States |
| Digestive Disorders Associate | Annapolis | Maryland | 21401 | United States |
| Woodholme Gastroenterology Associates, PA | Baltimore | Maryland | 21208 | United States |
| Digestive Diseases Associates, PA | Baltimore | Maryland | 21229 | United States |
| Chevy Chase Clinical Research MGG | Chevy Chase | Maryland | 20815 | United States |
| Clinical Associates Research | Reisterstown | Maryland | 21136 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| Northeast Medical Research Associates | North Dartmouth | Massachusetts | 02747 | United States |
| Ridgeview Research | Chaska | Minnesota | 55318 | United States |
| Gastrointestinal Associates, PA | Jackson | Mississippi | 39202 | United States |
| Olive Branch Family Medical Center | Olive Branch | Mississippi | 38654 | United States |
| St. Louis Center for Clinical Research | St Louis | Missouri | 63128 | United States |
| Montana Health Research Institute | Billings | Montana | 59102 | United States |
| Gastroenterology Specialties, PC | Lincoln | Nebraska | 68503 | United States |
| Dr. Meera Dewan, PC | Omaha | Nebraska | 68144 | United States |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
| New Mexico Clinical Research & Osteoporosis Center | Albuquerque | New Mexico | 87106 | United States |
| Long Island Clinical Research Associates | Great Neck | New York | 11021 | United States |
| Cornell Weill Medical College | New York | New York | 10021 | United States |
| Asheville Gastroenterology Associates, PA | Asheville | North Carolina | 28801 | United States |
| Cary Medical Research Associates | Cary | North Carolina | 27511 | United States |
| UNC Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| Charlotte Gastroenterology and Hepatology | Charlotte | North Carolina | 28207 | United States |
| Metrolina Medical Research | Charlotte | North Carolina | 28209 | United States |
| Cumberland Research Associates | Fayetteville | North Carolina | 28304 | United States |
| LeBauer research Associates, PA | Greensboro | North Carolina | 27403 | United States |
| Unifour Medical Research Associates | Hickory | North Carolina | 28601 | United States |
| Triangle Medical Research Associates | Raleigh | North Carolina | 27609 | United States |
| Crescent Medical Research | Salisbury | North Carolina | 28144 | United States |
| Hanover Medical Specialists, PA | Wilmington | North Carolina | 28401 | United States |
| New Hannover Medical Research | Wilmington | North Carolina | 28412 | United States |
| Piedmont Medical Research Associates | Winston-Salem | North Carolina | 27103 | United States |
| Akron Gastroenterology Assoc, Inc. | Akron | Ohio | 44302 | United States |
| Digestive Health Network | Cincinnati | Ohio | 45220 | United States |
| Radiant Research | Cincinnati | Ohio | 45249 | United States |
| Radiant Research | Columbus | Ohio | 43212 | United States |
| Wells Institute for Health Awareness | Kettering | Ohio | 45429 | United States |
| Radiant Research - Akron | Mogadore | Ohio | 44260 | United States |
| Lion Research | Norman | Oklahoma | 73701 | United States |
| Oklahoma Foundation for Digestive Research | Oklahoma City | Oklahoma | 73104 | United States |
| Options Health Research, LLC | Tulsa | Oklahoma | 74104 | United States |
| Castlerock Clinical Research Consultants, LLC | Tulsa | Oklahoma | 74136 | United States |
| NW Gastroenterology Clinic | Portland | Oregon | 97210 | United States |
| West Hills Gastroenterology Associates, PC | Portland | Oregon | 97225 | United States |
| Allegheny Center for Digestive Health | Pittsburgh | Pennsylvania | 15212 | United States |
| Guthrie Clinical Research | Sayre | Pennsylvania | 18840 | United States |
| Safe Harbor Clinical Research | East Providence | Rhode Island | 02917 | United States |
| Coastal Carolina Research Center | Mt. Pleasant | South Carolina | 29464 | United States |
| Palmetto Medical Research | Mt. Pleasant | South Carolina | 29464 | United States |
| Hillcrest Clinical Research | Simpsonville | South Carolina | 29681 | United States |
| ClinSearch | Chattanooga | Tennessee | 37404 | United States |
| Alpha Clinical Research,LLC | Clarksville | Tennessee | 37043 | United States |
| Memphis Gastroenterology Group | Germantown | Tennessee | 38138 | United States |
| Gastroenterology Associates | Kingsport | Tennessee | 37660 | United States |
| Dial Research Associates, Inc | Nashville | Tennessee | 37205 | United States |
| Covance CRU-Austin | Austin | Texas | 78752 | United States |
| Sadler Clinic | Conroe | Texas | 77304 | United States |
| Texas Tech University Health Sciences Center | El Paso | Texas | 79905 | United States |
| Discovery Alliance | Houston | Texas | 77004 | United States |
| NationsMed Clinical Research | Houston | Texas | 77036 | United States |
| Clinical Trials Network | Houston | Texas | 77074 | United States |
| Texas Tech University Health Sciences Center | Lubbock | Texas | 79430 | United States |
| Sun Research Institute | San Antonio | Texas | 78205 | United States |
| Advanced Research Institute | Ogden | Utah | 84405 | United States |
| J. Lewis Research Inc., Foothills Family Clinic | Salt Lake City | Utah | 84109 | United States |
| Charlottesville Medical Research | Charlottesville | Virginia | 22911 | United States |
| New River Valley Research Institute | Christiansburg | Virginia | 24073 | United States |
| National Clinical Research Inc | Richmond | Virginia | 23294 | United States |
| Wisconsin Center for Advanced Research | Milwaukee | Wisconsin | 53215 | United States |
| 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 |
|---|---|
| C092095 | asimadoline |
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