Study of Asimadoline to Treat Diarrhea-Predominant Irritable Bowel Syndrome (D-IBS)
- Conditions
- Diarrhea Predominant Irritable Bowel Syndrome
- Interventions
- Drug: Placebo
- Registration Number
- NCT01100684
- Lead Sponsor
- Tioga Pharmaceuticals
- Brief Summary
The purpose of this study is to determine whether asimadoline is safe and effective at treating D-IBS.
- Detailed Description
The primary objective of the study is to compare the efficacy of the two treatments with respect to improvement in IBS-related abdominal pain severity and reduction in stool frequency. During the 12-week treatment period, daily IBS-related abdominal pain severity score and daily frequency of bowel movements will be averaged over each week to determine average values for each endpoint. For each subject, weekly response to treatment will be based on the following parameters:
* 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 611
-
Signs and dates a written informed consent form.
-
Male and female subjects aged 18-79 who are fluent in English
-
All subjects must use protocol specified contraceptive measures
-
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
-
The subject has been diagnosed with diarrhea-predominant IBS
-
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.
- The subject exhibits evidence of a biochemical or structural abnormality of the digestive tract.
- 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).
- The subject has a family history of prolonged QT syndrome.
- The subject has been diagnosed with a major psychiatric disorder.
- The subject has a history of alcohol or substance abuse within the past 2 years.
- The subject has a history or current evidence of laxative abuse
- The subject has a positive stool sample for ova or parasite.
- The subject has used an investigational drug or participated in an investigational study within 30 days of screening.
- The subject refuses to discontinue one (or more) prohibited medications at least 7 days prior to the screening visit.
- 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.
- The subject is a pregnant woman or a woman who is breast feeding.
- The subject is unable or unwilling to follow directions or use the electronic diary system.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment Asimadoline 0.5 mg asimadoline bid Placebo Placebo Placebo
- Primary Outcome Measures
Name Time Method 12 Week Abdominal Pain and Stool (APS) Frequency Responder Weekly responder based on patient assessments made daily in each week of the 12-week Treatment Period to determine 12 week APS responder A study responder is a subject who has both a decrease from baseline of IBS-related abdominal pain and a decrease from baseline of daily bowel movements
- Secondary Outcome Measures
Name Time Method Compare the two treatment groups with respect to IBS-related abdominal pain Up to 12 weeks Incidence of adverse events as a measure of tolerability Up to 16 weeks Abnormalities of laboratory tests as a measure of tolerability Up to 16 weeks Compare the two treatment groups with respect to stool consistency scores Up to 12 weeks Using the Bristol Stool Form Scale
Compare the two treatment groups with respect to stool frequency Up to 12 weeks Compare the two treatment groups with respect to stool urgency Up to 12 weeks Compare the two treatment groups with respect to IBS symptoms up to 12 weeks
Trial Locations
- Locations (134)
Elkhart Clinic, LLC/Indiana Medical Research, LLC
🇺🇸Elkhart, Indiana, United States
Central Sooner Research
🇺🇸Norman, Oklahoma, United States
Illinois Center for Clinical Research
🇺🇸Chicago, Illinois, United States
Alliance Clinical Research
🇺🇸Winter Park, Florida, United States
Lynn Institute of the Ozarks
🇺🇸Little Rock, Arkansas, United States
GW Research Inc,
🇺🇸Chula Vista, California, United States
Adobe Clinical Research, LLC
🇺🇸Tucson, Arizona, United States
North Alabama Research Center, LLC
🇺🇸Athens, Alabama, United States
W/C Clinical Research
🇺🇸Tucson, Arizona, United States
Applied Research Center of Arkansas
🇺🇸Little Rock, Arkansas, United States
Meritus Center for Clinical Resarch
🇺🇸Hagerstown, Maryland, United States
Digestive & Liver Disease Specialist
🇺🇸Garden Grove, California, United States
A.G.A. Clinical Trials
🇺🇸Hialeah, Florida, United States
Clinical Research Institute of Michigan, LLC
🇺🇸Chesterfield, Michigan, United States
Lynn Institute of Pueblo
🇺🇸Pueblo, Colorado, United States
LeBauer Research Associates, P.A.
🇺🇸Greensboro, North Carolina, United States
Riverside Clinical Research
🇺🇸Edgewater, Florida, United States
Research Associates of New York
🇺🇸New York,, New York, United States
MediSphere Medical Research Center, LLC
🇺🇸Evansville, Indiana, United States
Gastrointestinal Clinic of Quad Cities
🇺🇸Davenport, Iowa, United States
Lynne Institute of the Rockies
🇺🇸Colorado Springs, Colorado, United States
DMI Research
🇺🇸Pinellas Park, Florida, United States
Gastrointestinal Accociates, PA
🇺🇸Jackson, Mississippi, United States
Digestive Research Specialist
🇺🇸Tupelo, Mississippi, United States
Long Island Clinical Research Associates, LLP
🇺🇸Great Neck, New York, United States
Tover Health Systems Center for Clinical Research
🇺🇸Madisonville, Kentucky, United States
Midwest Center for Clinical Research
🇺🇸Lees Summit, Missouri, United States
Hometown Urgent Care
🇺🇸Dayton, Ohio, United States
Safe Harbor Clinical Research
🇺🇸East Providence, Rhode Island, United States
Lakeview Medical Research
🇺🇸Summerfield, Florida, United States
Atlanta Center for Gastroenterology
🇺🇸Decatur, Georgia, United States
NECCR Internal Medicine and Cardiology Associates LLC
🇺🇸Fall River, Massachusetts, United States
Commonwealth Clinical Studies
🇺🇸Brockton, Massachusetts, United States
Atlantic Research Affiliates
🇺🇸Morristown, New Jersey, United States
Peters Medical Research
🇺🇸High Point, North Carolina, United States
Tri County Research
🇺🇸Hartwell, Georgia, United States
Gastroenterology Associates
🇺🇸Bristol, Tennessee, United States
Journey Clinical Research
🇺🇸Duncan, Oklahoma, United States
St. Louis Center for Clinical Research
🇺🇸St. Louis, Missouri, United States
Life Medi-Research
🇺🇸Brooklyn, New York, United States
Heartland Research Associates, LLC
🇺🇸Wichita, Kansas, United States
SC Clinical Research, LLC
🇺🇸Columbia, South Carolina, United States
Long Island Gastrointestinal Research Group
🇺🇸Great Neck, New York, United States
PMG Research of Hickory, LLC
🇺🇸Hickory, North Carolina, United States
Physicians Research, Inc
🇺🇸Zanesville, Ohio, United States
Akron Gastroenterology Associates
🇺🇸Akron, Ohio, United States
Hillcrest Clinical Research, LLC
🇺🇸Simpsonville, South Carolina, United States
Gastrointestinal Research Associates, LLC
🇺🇸Setauket, New York, United States
Kinston Medical Specialist, P.A.
🇺🇸Kinston, North Carolina, United States
Gastroenterology, Ltd.
🇺🇸Virginia Beach, Virginia, United States
Trial Management Associates LLC
🇺🇸Wilmington, North Carolina, United States
Research Across America/ Family Medicine Associates of Texas
🇺🇸Carrollton, Texas, United States
TN Medical Research
🇺🇸Spring Hill, Tennessee, United States
Wake Research Associates
🇺🇸Raleigh, North Carolina, United States
Coastal Carolina Research Center in Goose Creek
🇺🇸Goose Creek, South Carolina, United States
Gastroenterology Associates Clinical Research
🇺🇸Kingsport, Tennessee, United States
Digestive Health Associates of Texas
🇺🇸Plano, Texas, United States
Houston S. Endoscopy and Research Center
🇺🇸Houston, Texas, United States
Advanced Research Institute
🇺🇸Sandy, Utah, United States
Medical Center for Clinical Research
🇺🇸San Diego, California, United States
Medical Associates Research Group, Inc.
🇺🇸San Diego, California, United States
FIRC
🇺🇸Miami, Florida, United States
Gastroenterology Research Consultants of Greater Cincinnati
🇺🇸Cincinnati, Ohio, United States
Gastroenterology Consultants, P.A.
🇺🇸Houston, Texas, United States
Pioneer Research Solutions, Inc
🇺🇸Houston, Texas, United States
Sun Research Institute
🇺🇸San Antonio, Texas, United States
Clinical Trials of Texas
🇺🇸San Antonio, Texas, 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
Columbia Medical Group -The First Clinic, Inc.
🇺🇸Nashville, Tennessee, United States
Dial Research Associates, INC
🇺🇸Nashville, Tennessee, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Dr. Meera Dewan PC
🇺🇸Omaha, Nebraska, United States
Northwest Gastroenterology Clinic, LLC
🇺🇸Portland, Oregon, United States
Wisconsin Center for Advanced Research
🇺🇸Milwaukee, Wisconsin, United States
Connect Clinical Research Center
🇺🇸Chandler, Arizona, United States
Digestive Health Research Unit
🇺🇸Scottsdale, Arizona, United States
ACRC/Arizona Clinical Research Center, Inc.
🇺🇸Tucson, Arizona, United States
Genova Clinical Research
🇺🇸Tucson, Arizona, United States
Providence Clinical Research
🇺🇸Burbank, California, United States
Discovery Clinical Research
🇺🇸Encinitas, California, United States
Arkansas Gastroenterology
🇺🇸Sherwood, Arkansas, United States
La Jolla Clinical Research, Inc
🇺🇸Chula Vista, 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
Meridien Research
🇺🇸Brookville, Florida, United States
Westlake Medical Research
🇺🇸Westlake Village, California, United States
Danbury Clinical Research, LLC
🇺🇸Danbury, Connecticut, United States
Chase Medical Research, LLC
🇺🇸Waterbury, Connecticut, United States
BioPharma Research
🇺🇸Coral Gables, Florida, United States
Center for Advanced Gastroenterology
🇺🇸Maitland, Florida, United States
International Clinical Research-US,LLC
🇺🇸Sanford, Florida, United States
Accord Clinical Research, LLC
🇺🇸Port Orange, Florida, United States
Venra Clinical Studies, LLC
🇺🇸Wellington, Florida, United States
Northwest Gastroenterologist S.C.
🇺🇸Arlington Heights, Illinois, United States
Tri-State Gastroenterology Associates, PSC
🇺🇸Crestview Hills, Kentucky, United States
Mercy Gastroenterology Clinic
🇺🇸Clive, Iowa, United States
Montana Health Research Institute, Inc.
🇺🇸Billings, Montana, United States
Anderson & Collins Clinical Research
🇺🇸Edison, New Jersey, United States
Memphis Gastroenterology Group
🇺🇸Germantown, Tennessee, United States
Midwest Medical Care
🇺🇸Sioux Falls, South Dakota, United States
Alpha Clinical Research
🇺🇸Clarksville, Tennessee, United States
Associates in Gastroenterology
🇺🇸Hermitage, Tennessee, United States
Saadat Ansari MD LLC
🇺🇸Huntsville, Alabama, United States
ClinSearch, LLC
🇺🇸Chattanooga, Tennessee, United States
Southwest Gastroenterology
🇺🇸Oak Lawn, Illinois, United States
Sutter Medical Group Gastroenterology
🇺🇸Sacramento, California, United States
The Research Group of Lexington, LLC
🇺🇸Lexington, Kentucky, United States
University of Louisville Medical-Dental Complex
🇺🇸Louisville, Kentucky, United States
University of Michigan Health System
🇺🇸Ann Arbor, Michigan, United States
The UNC Center for Functional GI and Motility Disorders
🇺🇸Chapel Hill, North Carolina, United States
PMG Research of Winston-Salem
🇺🇸Winston-Salem, North Carolina, United States
Southeast Medical Research
🇺🇸Charleston, South Carolina, United States
Arapahoe Gastroenterology
🇺🇸Littleton, Colorado, United States
Saginaw Valley Medical Research Group, LLC
🇺🇸Saginaw, Michigan, United States
Hometown Urgent Care and Research
🇺🇸Miamisburg, Ohio, United States
South Jersey Gastroenterology. P.A.
🇺🇸Marlton, New Jersey, United States
Premier Medical Group of the Hudson Valley
🇺🇸Poughkeepsie, New York, United States
Corsicana Medical Research, PLLC
🇺🇸Corsicana, Texas, United States
Medical Affliated Research Center, Inc.
🇺🇸Huntsville, Alabama, United States
Investigative Clinical Research
🇺🇸Annapolis, Maryland, United States
Graves-Gilbert Clinic
🇺🇸Bowling Green, Kentucky, United States
ActivMed Practices and Research
🇺🇸Haverhill, Massachusetts, United States
Winthrop University Hospital Clinical Trials Center
🇺🇸Mineola, New York, United States
Rocky Mountain Gastroenterology Associates
🇺🇸Thornton, Colorado, United States
Consultants for Clinical Research of South Florida
🇺🇸Boynton Beach, Florida, United States
Altus Research
🇺🇸Lake Worth, Florida, United States
PMG Research of Charlotte, LLC
🇺🇸Charlotte, North Carolina, United States
Texas University Health Sciences Center
🇺🇸El Paso, Texas, United States
Spectrum Clinical Research Inc.
🇺🇸Towson, Maryland, United States
Center for Digestive and Liver Diseases, Inc.
🇺🇸Mexico, Missouri, United States
Lillestol Research LLC
🇺🇸Fargo, North Dakota, United States