Asimadoline for the Treatment of Subjects With Irritable Bowel Syndrome
- Registration Number
- NCT00454688
- Lead Sponsor
- Tioga Pharmaceuticals
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 596
- Males and females aged 18-79
- Must sign an ICF
- Females of childbearing potential must have a negative pregnancy test at screening and must adhere to contraception throughout the trial
- Must have been diagnosed with IBS as a result of having at least 6 months, not necessarily consecutive, in the preceding 12 months of recurrent symptoms of abdominal discomfort or pain associated with at least 2 of the following: 1)relieved with defecation; 2)onset associated with a change in stool frequency; 3)onset associated with a change in stool form
- Must demonstrate a willingness to comply with daily telephone diary entry
- Any subject with evidence of a biochemical or structural abnormality of the digestive tract or other co-morbid illness that might impact the ability to interpret the safety and efficacy data
- Pregnant or breastfeeding females
- Refusal to discontinue prohibited concomitant medications
- Use of an investigational drug or participation in an investigational study within 30 days of screening
- Inability or unwillingness to use the touch-tone telephone data entry system
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - Asimadoline 0.15 mg Asimadoline - Asimadoline 0.5 mg Asimadoline - Asimadoline 1.0 mg Asimadoline -
- Primary Outcome Measures
Name Time Method Relief of IBS Pain - total months 12 weeks The primary efficacy endpoint of the study was the total number of months with adequate relief of IBS pain or discomfort.
- Secondary Outcome Measures
Name Time Method Relief of IBS Pain - percent of patients 12 weeks Proportion of subjects with adequate relief of IBS pain or discomfort
Relief of IBS Symptoms 12 weeks Adequate relief of IBS symptoms
Lower GI function - change from baseline 12 weeks Change from baseline in assessments of lower gastrointestinal (GI) function (i.e., stool frequency, stool consistency, urgency, bloating, and straining)
Abdominal Pain Score - change from baseline 12 weeks Change from baseline in abdominal pain score
Abdominal Discomfort Score - change from baseline 12 weeks Change from baseline in abdominal discomfort score
Trial Locations
- Locations (106)
Allegheny Center for Digestive Health
🇺🇸Pittsburgh, Pennsylvania, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Discovery Alliance
🇺🇸Houston, Texas, United States
NationsMed Clinical Research
🇺🇸Houston, Texas, United States
Clinical Trials Network
🇺🇸Houston, Texas, United States
New River Valley Research Institute
🇺🇸Christiansburg, Virginia, United States
Genova Clinical Research
🇺🇸Tucson, Arizona, United States
Community Clinical Trials
🇺🇸Orange, California, United States
Digestive & Liver Disease Specialists
🇺🇸Garden Grove, California, United States
Gastrointestinal Associates, PA
🇺🇸Jackson, Mississippi, United States
Olive Branch Family Medical Center
🇺🇸Olive Branch, Mississippi, United States
Asheville Gastroenterology Associates, PA
🇺🇸Asheville, North Carolina, United States
Mayo Clinic Scottsdale - Division of Gastroenterology
🇺🇸Scottsdale, Arizona, United States
Lovelace Scientific Resources
🇺🇸Sarasota, Florida, United States
Lynn Institute of the Rockies
🇺🇸Colorado Springs, Colorado, United States
Irvine Center for Clinical Research Inc.
🇺🇸Irvine, California, United States
Ridgeview Research
🇺🇸Chaska, Minnesota, United States
Long Island Clinical Research Associates
🇺🇸Great Neck, New York, United States
Western States Clinical Research Inc
🇺🇸Wheat Ridge, Colorado, United States
Options Health Research, LLC
🇺🇸Tulsa, Oklahoma, United States
Radiant Research - Akron
🇺🇸Mogadore, Ohio, United States
Metrolina Medical Research
🇺🇸Charlotte, North Carolina, United States
Clinical Associates Research
🇺🇸Reisterstown, Maryland, United States
Chevy Chase Clinical Research MGG
🇺🇸Chevy Chase, Maryland, United States
Northeast Medical Research Associates
🇺🇸North Dartmouth, Massachusetts, United States
St. Louis Center for Clinical Research
🇺🇸St. Louis, Missouri, United States
Gastroenterology Specialties, PC
🇺🇸Lincoln, Nebraska, United States
Unifour Medical Research Associates
🇺🇸Hickory, North Carolina, United States
Charlottesville Medical Research
🇺🇸Charlottesville, Virginia, United States
Coastal Carolina Research Center
🇺🇸Mt. Pleasant, South Carolina, United States
Akron Gastroenterology Assoc, Inc.
🇺🇸Akron, Ohio, United States
Guthrie Clinical Research
🇺🇸Sayre, Pennsylvania, United States
Digestive Health Network
🇺🇸Cincinnati, Ohio, United States
Sun Research Institute
🇺🇸San Antonio, Texas, United States
Cumberland Research Associates
🇺🇸Fayetteville, North Carolina, United States
Crescent Medical Research
🇺🇸Salisbury, North Carolina, United States
Sadler Clinic
🇺🇸Conroe, Texas, United States
Memphis Gastroenterology Group
🇺🇸Germantown, Tennessee, United States
Advanced Research Institute
🇺🇸Ogden, Utah, United States
Cary Medical Research Associates
🇺🇸Cary, North Carolina, United States
Charlotte Gastroenterology and Hepatology
🇺🇸Charlotte, North Carolina, United States
New Hannover Medical Research
🇺🇸Wilmington, North Carolina, United States
Safe Harbor Clinical Research
🇺🇸East Providence, Rhode Island, United States
Hillcrest Clinical Research
🇺🇸Simpsonville, South Carolina, United States
Castlerock Clinical Research Consultants, LLC
🇺🇸Tulsa, Oklahoma, United States
Lion Research
🇺🇸Norman, Oklahoma, United States
Hanover Medical Specialists, PA
🇺🇸Wilmington, North Carolina, United States
Texas Tech University Health Sciences Center
🇺🇸Lubbock, Texas, United States
Redpoint Research
🇺🇸Phoenix, Arizona, United States
Oklahoma Foundation for Digestive Research
🇺🇸Oklahoma City, Oklahoma, United States
Dial Research Associates, Inc
🇺🇸Nashville, Tennessee, United States
J. Lewis Research Inc., Foothills Family Clinic
🇺🇸Salt Lake City, Utah, United States
NW Gastroenterology Clinic
🇺🇸Portland, Oregon, United States
West Hills Gastroenterology Associates, PC
🇺🇸Portland, Oregon, United States
Covance CRU-Austin
🇺🇸Austin, Texas, United States
National Clinical Research Inc
🇺🇸Richmond, Virginia, United States
Medical Affiliated Research Center
🇺🇸Huntsville, Alabama, United States
Arkansas Gastroenterology
🇺🇸North Little Rock, Arkansas, United States
Phoenix Internal Medicine Associates, LLC
🇺🇸Waterbury, Connecticut, United States
Westlake Medical Research
🇺🇸Westlake Village, California, United States
Longmont Medical Research Network
🇺🇸Longmont, Colorado, United States
Suncoast Clinical Research
🇺🇸New Port Richey, Florida, United States
Clinical Research Consultants, LLC
🇺🇸Stratford, Connecticut, United States
Research Consultants Group
🇺🇸Hialeah, Florida, United States
Meridian Research
🇺🇸Brooksville, Florida, United States
Penninsula Research, Inc
🇺🇸Ormond Beach, Florida, United States
Radiant Research - St. Petersburg
🇺🇸Pinellas Park, Florida, United States
Michael S. Levine, MD
🇺🇸Marietta, Georgia, United States
Illinois Center for Clinical Research
🇺🇸Chicago, Illinois, United States
Clinical Research Atlanta
🇺🇸Stockbridge, Georgia, United States
Mount Vernon Clinical Research
🇺🇸Sandy Springs, Georgia, United States
BHS Digestive Disease Associates
🇺🇸Riverside, Illinois, United States
Northwest Gastroenterologists S.C.
🇺🇸Arlington Heights, Illinois, United States
Heartland Medical Research, Inc
🇺🇸Clive, Iowa, United States
University Digestive Health Center
🇺🇸Oak Forest, Illinois, United States
Indianapolis Gastroenterology Research Foundation
🇺🇸Indianapolis, Indiana, United States
Rockford Gastroenterology Associates Ltd
🇺🇸Rockford, Illinois, United States
Professional Research Network of Kansas
🇺🇸Wichita, Kansas, United States
Digestive Health Center of Louisianna
🇺🇸Baton Rouge, Louisiana, United States
Woodholme Gastroenterology Associates, PA
🇺🇸Baltimore, Maryland, United States
Digestive Disorders Associate
🇺🇸Annapolis, Maryland, United States
Digestive Diseases Associates, PA
🇺🇸Baltimore, Maryland, United States
Cornell Weill Medical College
🇺🇸New York, New York, United States
LeBauer research Associates, PA
🇺🇸Greensboro, North Carolina, United States
Triangle Medical Research Associates
🇺🇸Raleigh, North Carolina, United States
Wells Institute for Health Awareness
🇺🇸Kettering, Ohio, United States
Palmetto Medical Research
🇺🇸Mt. Pleasant, South Carolina, United States
Alpha Clinical Research,LLC
🇺🇸Clarksville, Tennessee, United States
ClinSearch
🇺🇸Chattanooga, Tennessee, United States
Gastroenterology Associates
🇺🇸Kingsport, Tennessee, United States
Montana Health Research Institute
🇺🇸Billings, Montana, United States
Meridien Research
🇺🇸Tampa, Florida, United States
Dr. Meera Dewan, PC
🇺🇸Omaha, Nebraska, United States
Sutter Institute for Medical Research
🇺🇸Sacramento, California, United States
Nothern California Research
🇺🇸Sacramento, California, United States
Universal Clinical Research & Technology
🇺🇸Orlando, Florida, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
University of Louisville GI Research
🇺🇸Louisville, Kentucky, United States
UNC Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Piedmont Medical Research Associates
🇺🇸Winston-Salem, North Carolina, United States
Wisconsin Center for Advanced Research
🇺🇸Milwaukee, Wisconsin, United States
Florida Medical Research Institute
🇺🇸Gainesville, Florida, United States
New Mexico Clinical Research & Osteoporosis Center
🇺🇸Albuquerque, New Mexico, United States
Heartland Research Associates, LLC
🇺🇸Wichita, Kansas, United States
Commonwealth Biomedical Research, LLC
🇺🇸Madisonville, Kentucky, United States
Radiant Research
🇺🇸Columbus, Ohio, United States