Study of Asimadoline to Treat Diarrhea-Predominant Irritable Bowel Syndrome (D-IBS)
NCT ID: NCT01100684
Last Updated: 2013-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
611 participants
INTERVENTIONAL
2010-05-31
2013-06-30
Brief Summary
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Detailed Description
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* Decrease from baseline of at least 30% in the average IBS-related daily abdominal pain severity score
* Decrease from baseline of at least 25% in the average number of daily bowel movements A subject must meet both criteria to be considered a weekly responder. The primary efficacy endpoint is based on an "overall study responder," defined as a subject having 6 or more weeks of weekly response to treatment out of the 12 weeks in the treatment period. Overall study responder will be stratified by timing of bowel preparation and endoscopy.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Treatment
0.5 mg asimadoline bid
Asimadoline
0.5 mg Asimadoline BID
Placebo
Placebo
Placebo
Placebo
Interventions
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Asimadoline
0.5 mg Asimadoline BID
Placebo
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Male and female subjects aged 18-79 who are fluent in English
3. All subjects must use protocol specified contraceptive measures
4. The subject is or has been diagnosed with IBS with symptom onset at least 6 months prior to diagnosis. IBS is defined as the subject having recurrent abdominal pain or discomfort at least 3 days per month in the past 3 months associated with at least two of the following symptoms:
Improvement with defecation Onset associated with a change in frequency of stool Onset associated with a change in form (appearance) of stool
5. The subject has been diagnosed with diarrhea-predominant IBS
6. Within 2 years of the randomization visit, the subject has normal results from a flexible sigmoidoscopy, a colonoscopy, or a barium enema plus flexible sigmoidoscopy, according to the subject's age by a specified algorithm.
Exclusion Criteria
2. Subject has a concurrent illness or disability (excluding IBS) that may affect the interpretation of clinical efficacy and/or safety data or otherwise contraindicates participation in this clinical study (e.g., an unstable cardiovascular, renal, hepatic, pulmonary, endocrine, metabolic, GI, hematological, or neurological condition).
3. The subject has a family history of prolonged QT syndrome.
4. The subject has been diagnosed with a major psychiatric disorder.
5. The subject has a history of alcohol or substance abuse within the past 2 years.
6. The subject has a history or current evidence of laxative abuse
7. The subject has a positive stool sample for ova or parasite.
8. The subject has used an investigational drug or participated in an investigational study within 30 days of screening.
9. The subject refuses to discontinue one (or more) prohibited medications at least 7 days prior to the screening visit.
10. The subject refuses to maintain a stable dose of one (or more) allowable concurrent medications for at least 30 days prior to the screening visit.
11. The subject is a pregnant woman or a woman who is breast feeding.
12. The subject is unable or unwilling to follow directions or use the electronic diary system.
18 Years
79 Years
ALL
No
Sponsors
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RTI Health Solutions
OTHER
Tioga Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Allen Mangel, M.D.Ph.D.
Role: STUDY_CHAIR
CMO
Locations
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North Alabama Research Center, LLC
Athens, Alabama, United States
Alliance Clinical Research
Birmingham, Alabama, United States
Medical Affliated Research Center, Inc.
Huntsville, Alabama, United States
Saadat Ansari MD LLC
Huntsville, Alabama, United States
Connect Clinical Research Center
Chandler, Arizona, United States
Digestive Health Research Unit
Scottsdale, Arizona, United States
Adobe Clinical Research, LLC
Tucson, Arizona, United States
ACRC/Arizona Clinical Research Center, Inc.
Tucson, Arizona, United States
Genova Clinical Research
Tucson, Arizona, United States
W/C Clinical Research
Tucson, Arizona, United States
Lynn Institute of the Ozarks
Little Rock, Arkansas, United States
Applied Research Center of Arkansas
Little Rock, Arkansas, United States
Arkansas Gastroenterology
Sherwood, Arkansas, United States
Providence Clinical Research
Burbank, California, United States
GW Research Inc,
Chula Vista, California, United States
La Jolla Clinical Research, Inc
Chula Vista, California, United States
Discovery Clinical Research
Encinitas, California, United States
Digestive & Liver Disease Specialist
Garden Grove, California, United States
Collaborative Neuroscience Network Inc
Long Beach, California, United States
California Gastroenterology Associates
Madera, California, United States
Community Clinical Trials
Orange, California, United States
Sutter Medical Group Gastroenterology
Sacramento, California, United States
Medical Center for Clinical Research
San Diego, California, United States
Medical Associates Research Group, Inc.
San Diego, California, United States
Westlake Medical Research
Westlake Village, California, United States
Lynne Institute of the Rockies
Colorado Springs, Colorado, United States
Arapahoe Gastroenterology
Littleton, Colorado, United States
Lynn Institute of Pueblo
Pueblo, Colorado, United States
Rocky Mountain Gastroenterology Associates
Thornton, Colorado, United States
Danbury Clinical Research, LLC
Danbury, Connecticut, United States
Chase Medical Research, LLC
Waterbury, Connecticut, United States
Consultants for Clinical Research of South Florida
Boynton Beach, Florida, United States
Meridien Research
Brookville, Florida, United States
BioPharma Research
Coral Gables, Florida, United States
Riverside Clinical Research
Edgewater, Florida, United States
A.G.A. Clinical Trials
Hialeah, Florida, United States
Altus Research
Lake Worth, Florida, United States
Center for Advanced Gastroenterology
Maitland, Florida, United States
FIRC
Miami, Florida, United States
DMI Research
Pinellas Park, Florida, United States
Accord Clinical Research, LLC
Port Orange, Florida, United States
International Clinical Research-US,LLC
Sanford, Florida, United States
Lakeview Medical Research
Summerfield, Florida, United States
Venra Clinical Studies, LLC
Wellington, Florida, United States
Alliance Clinical Research
Winter Park, Florida, United States
Atlanta Center for Gastroenterology
Decatur, Georgia, United States
Tri County Research
Hartwell, Georgia, United States
Northwest Gastroenterologist S.C.
Arlington Heights, Illinois, United States
Illinois Center for Clinical Research
Chicago, Illinois, United States
Southwest Gastroenterology
Oak Lawn, Illinois, United States
Elkhart Clinic, LLC/Indiana Medical Research, LLC
Elkhart, Indiana, United States
MediSphere Medical Research Center, LLC
Evansville, Indiana, United States
Mercy Gastroenterology Clinic
Clive, Iowa, United States
Gastrointestinal Clinic of Quad Cities
Davenport, Iowa, United States
Heartland Research Associates, LLC
Newton, Kansas, United States
Heartland Research Associates, LLC
Wichita, Kansas, United States
Graves-Gilbert Clinic
Bowling Green, Kentucky, United States
Tri-State Gastroenterology Associates, PSC
Crestview Hills, Kentucky, United States
Hometown Urgent Care and Research
Hebron, Kentucky, United States
The Research Group of Lexington, LLC
Lexington, Kentucky, United States
University of Louisville Medical-Dental Complex
Louisville, Kentucky, United States
Tover Health Systems Center for Clinical Research
Madisonville, Kentucky, United States
Investigative Clinical Research
Annapolis, Maryland, United States
Meritus Center for Clinical Resarch
Hagerstown, Maryland, United States
Spectrum Clinical Research Inc.
Towson, Maryland, United States
Commonwealth Clinical Studies
Brockton, Massachusetts, United States
NECCR Internal Medicine and Cardiology Associates LLC
Fall River, Massachusetts, United States
ActivMed Practices and Research
Haverhill, Massachusetts, United States
University of Michigan Health System
Ann Arbor, Michigan, United States
Clinical Research Institute of Michigan, LLC
Chesterfield, Michigan, United States
Saginaw Valley Medical Research Group, LLC
Saginaw, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Gastrointestinal Accociates, PA
Jackson, Mississippi, United States
Digestive Research Specialist
Tupelo, Mississippi, United States
Midwest Center for Clinical Research
Lees Summit, Missouri, United States
Center for Digestive and Liver Diseases, Inc.
Mexico, Missouri, United States
St. Louis Center for Clinical Research
St Louis, Missouri, United States
Montana Health Research Institute, Inc.
Billings, Montana, United States
Dr. Meera Dewan PC
Omaha, Nebraska, United States
Anderson & Collins Clinical Research
Edison, New Jersey, United States
South Jersey Gastroenterology. P.A.
Marlton, New Jersey, United States
Atlantic Research Affiliates
Morristown, New Jersey, United States
Life Medi-Research
Brooklyn, New York, United States
Long Island Clinical Research Associates, LLP
Great Neck, New York, United States
Long Island Gastrointestinal Research Group
Great Neck, New York, United States
Winthrop University Hospital Clinical Trials Center
Mineola, New York, United States
Research Associates of New York
New York, New York, United States
Premier Medical Group of the Hudson Valley
Poughkeepsie, New York, United States
Gastrointestinal Research Associates, LLC
Setauket, New York, United States
The UNC Center for Functional GI and Motility Disorders
Chapel Hill, North Carolina, United States
PMG Research of Charlotte, LLC
Charlotte, North Carolina, United States
LeBauer Research Associates, P.A.
Greensboro, North Carolina, United States
PMG Research of Hickory, LLC
Hickory, North Carolina, United States
Peters Medical Research
High Point, North Carolina, United States
Kinston Medical Specialist, P.A.
Kinston, North Carolina, United States
Wake Research Associates
Raleigh, North Carolina, United States
Trial Management Associates LLC
Wilmington, North Carolina, United States
PMG Research of Winston-Salem
Winston-Salem, North Carolina, United States
Lillestol Research LLC
Fargo, North Dakota, United States
Akron Gastroenterology Associates
Akron, Ohio, United States
Gastroenterology Research Consultants of Greater Cincinnati
Cincinnati, Ohio, United States
Hometown Urgent Care
Columbus, Ohio, United States
Hometown Urgent Care
Dayton, Ohio, United States
Hometown Urgent Care and Research
Groveport, Ohio, United States
Hometown Urgent Care and Research
Miamisburg, Ohio, United States
Physicians Research, Inc
Zanesville, Ohio, United States
Journey Clinical Research
Duncan, Oklahoma, United States
Central Sooner Research
Norman, Oklahoma, United States
Oklahoma Foundation for Digestive Research
Oklahoma City, Oklahoma, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States
Sooner Clinical Research
Oklahoma City, Oklahoma, United States
Northwest Gastroenterology Clinic, LLC
Portland, Oregon, United States
Safe Harbor Clinical Research
East Providence, Rhode Island, United States
Southeast Medical Research
Charleston, South Carolina, United States
SC Clinical Research, LLC
Columbia, South Carolina, United States
Coastal Carolina Research Center in Goose Creek
Goose Creek, South Carolina, United States
Hillcrest Clinical Research, LLC
Simpsonville, South Carolina, United States
Midwest Medical Care
Sioux Falls, South Dakota, United States
Gastroenterology Associates
Bristol, Tennessee, United States
ClinSearch, LLC
Chattanooga, Tennessee, United States
Alpha Clinical Research
Clarksville, Tennessee, United States
Memphis Gastroenterology Group
Germantown, Tennessee, United States
Associates in Gastroenterology
Hermitage, Tennessee, United States
Gastroenterology Associates Clinical Research
Kingsport, Tennessee, United States
Columbia Medical Group -The First Clinic, Inc.
Nashville, Tennessee, United States
Dial Research Associates, INC
Nashville, Tennessee, United States
TN Medical Research
Spring Hill, Tennessee, United States
Research Across America/ Family Medicine Associates of Texas
Carrollton, Texas, United States
Corsicana Medical Research, PLLC
Corsicana, Texas, United States
Texas University Health Sciences Center
El Paso, Texas, United States
Gastroenterology Consultants, P.A.
Houston, Texas, United States
Houston S. Endoscopy and Research Center
Houston, Texas, United States
Pioneer Research Solutions, Inc
Houston, Texas, United States
Digestive Health Associates of Texas
Plano, Texas, United States
Sun Research Institute
San Antonio, Texas, United States
Clinical Trials of Texas
San Antonio, Texas, United States
Advanced Research Institute
Clinton, Utah, United States
Advanced Research Institute
Logan, Utah, United States
Advanced Research Institute
Ogden, Utah, United States
Advanced Research Institute
Sandy City, Utah, United States
Gastroenterology, Ltd.
Virginia Beach, Virginia, United States
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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ASMP3001
Identifier Type: -
Identifier Source: org_study_id