Asimadoline for the Treatment of Subjects With Irritable Bowel Syndrome
NCT ID: NCT00454688
Last Updated: 2011-10-18
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
PHASE2
596 participants
INTERVENTIONAL
2006-08-31
2007-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Placebo
Placebo was provided in coated tablets identical in appearance to asimadoline tablets.
Asimadoline 0.15 mg
Asimadoline
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
Asimadoline 0.5 mg
Asimadoline
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
Asimadoline 1.0 mg
Asimadoline
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
Interventions
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Asimadoline
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
Placebo
Placebo was provided in coated tablets identical in appearance to asimadoline tablets.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
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, MD, PhD
Role: STUDY_CHAIR
Tioga Pharmaceuticals
Locations
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Medical Affiliated Research Center
Huntsville, Alabama, United States
Lovelace Scientific Resources
Pheonix, Arizona, United States
Lovelace Scientific Resources
Phoenix, Arizona, United States
Redpoint Research
Phoenix, Arizona, United States
Mayo Clinic Scottsdale - Division of Gastroenterology
Scottsdale, Arizona, United States
Genova Clinical Research
Tucson, Arizona, United States
Arkansas Gastroenterology
North Little Rock, Arkansas, United States
Sutter Institute for Medical Research
Elk Grove, California, United States
Digestive & Liver Disease Specialists
Garden Grove, California, United States
Irvine Center for Clinical Research Inc.
Irvine, California, United States
Community Clinical Trials
Orange, California, United States
Sutter Institute for Medical Research
Sacramento, California, United States
Nothern California Research
Sacramento, California, United States
Westlake Medical Research
Westlake Village, California, United States
Lynn Institute of the Rockies
Colorado Springs, Colorado, United States
Longmont Medical Research Network
Longmont, Colorado, United States
Western States Clinical Research Inc
Wheat Ridge, Colorado, United States
Clinical Research Consultants, LLC
Stratford, Connecticut, United States
Phoenix Internal Medicine Associates, LLC
Waterbury, Connecticut, United States
Meridian Research
Brooksville, Florida, United States
Florida Medical Research Institute
Gainesville, Florida, United States
Research Consultants Group
Hialeah, Florida, United States
Suncoast Clinical Research
New Port Richey, Florida, United States
Universal Clinical Research & Technology
Orlando, Florida, United States
Penninsula Research, Inc
Ormond Beach, Florida, United States
Radiant Research - St. Petersburg
Pinellas Park, Florida, United States
Lovelace Scientific Resources
Sarasota, Florida, United States
Meridien Research
St. Petersburg, Florida, United States
Meridien Research
Tampa, Florida, United States
Michael S. Levine, MD
Marietta, Georgia, United States
Mount Vernon Clinical Research
Sandy Springs, Georgia, United States
Clinical Research Atlanta
Stockbridge, Georgia, United States
Northwest Gastroenterologists S.C.
Arlington Heights, Illinois, United States
Illinois Center for Clinical Research
Chicago, Illinois, United States
University Digestive Health Center
Oak Forest, Illinois, United States
BHS Digestive Disease Associates
Riverside, Illinois, United States
Rockford Gastroenterology Associates Ltd
Rockford, Illinois, United States
Indianapolis Gastroenterology Research Foundation
Indianapolis, Indiana, United States
Heartland Medical Research, Inc
Clive, Iowa, United States
Professional Research Network of Kansas
Wichita, Kansas, United States
Heartland Research Associates, LLC
Wichita, Kansas, United States
University of Louisville GI Research
Louisville, Kentucky, United States
Commonwealth Biomedical Research, LLC
Madisonville, Kentucky, United States
Digestive Health Center of Louisianna
Baton Rouge, Louisiana, United States
Digestive Disorders Associate
Annapolis, Maryland, United States
Woodholme Gastroenterology Associates, PA
Baltimore, Maryland, United States
Digestive Diseases Associates, PA
Baltimore, Maryland, United States
Chevy Chase Clinical Research MGG
Chevy Chase, Maryland, United States
Clinical Associates Research
Reisterstown, Maryland, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Northeast Medical Research Associates
North Dartmouth, Massachusetts, United States
Ridgeview Research
Chaska, Minnesota, United States
Gastrointestinal Associates, PA
Jackson, Mississippi, United States
Olive Branch Family Medical Center
Olive Branch, Mississippi, United States
St. Louis Center for Clinical Research
St Louis, Missouri, United States
Montana Health Research Institute
Billings, Montana, United States
Gastroenterology Specialties, PC
Lincoln, Nebraska, United States
Dr. Meera Dewan, PC
Omaha, Nebraska, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
New Mexico Clinical Research & Osteoporosis Center
Albuquerque, New Mexico, United States
Long Island Clinical Research Associates
Great Neck, New York, United States
Cornell Weill Medical College
New York, New York, United States
Asheville Gastroenterology Associates, PA
Asheville, North Carolina, United States
Cary Medical Research Associates
Cary, North Carolina, United States
UNC Chapel Hill
Chapel Hill, North Carolina, United States
Charlotte Gastroenterology and Hepatology
Charlotte, North Carolina, United States
Metrolina Medical Research
Charlotte, North Carolina, United States
Cumberland Research Associates
Fayetteville, North Carolina, United States
LeBauer research Associates, PA
Greensboro, North Carolina, United States
Unifour Medical Research Associates
Hickory, North Carolina, United States
Triangle Medical Research Associates
Raleigh, North Carolina, United States
Crescent Medical Research
Salisbury, North Carolina, United States
Hanover Medical Specialists, PA
Wilmington, North Carolina, United States
New Hannover Medical Research
Wilmington, North Carolina, United States
Piedmont Medical Research Associates
Winston-Salem, North Carolina, United States
Akron Gastroenterology Assoc, Inc.
Akron, Ohio, United States
Digestive Health Network
Cincinnati, Ohio, United States
Radiant Research
Cincinnati, Ohio, United States
Radiant Research
Columbus, Ohio, United States
Wells Institute for Health Awareness
Kettering, Ohio, United States
Radiant Research - Akron
Mogadore, Ohio, United States
Lion Research
Norman, Oklahoma, United States
Oklahoma Foundation for Digestive Research
Oklahoma City, Oklahoma, United States
Options Health Research, LLC
Tulsa, Oklahoma, United States
Castlerock Clinical Research Consultants, LLC
Tulsa, Oklahoma, United States
NW Gastroenterology Clinic
Portland, Oregon, United States
West Hills Gastroenterology Associates, PC
Portland, Oregon, United States
Allegheny Center for Digestive Health
Pittsburgh, Pennsylvania, United States
Guthrie Clinical Research
Sayre, Pennsylvania, United States
Safe Harbor Clinical Research
East Providence, Rhode Island, United States
Coastal Carolina Research Center
Mt. Pleasant, South Carolina, United States
Palmetto Medical Research
Mt. Pleasant, South Carolina, United States
Hillcrest Clinical Research
Simpsonville, South Carolina, United States
ClinSearch
Chattanooga, Tennessee, United States
Alpha Clinical Research,LLC
Clarksville, Tennessee, United States
Memphis Gastroenterology Group
Germantown, Tennessee, United States
Gastroenterology Associates
Kingsport, Tennessee, United States
Dial Research Associates, Inc
Nashville, Tennessee, United States
Covance CRU-Austin
Austin, Texas, United States
Sadler Clinic
Conroe, Texas, United States
Texas Tech University Health Sciences Center
El Paso, Texas, United States
Discovery Alliance
Houston, Texas, United States
NationsMed Clinical Research
Houston, Texas, United States
Clinical Trials Network
Houston, Texas, United States
Texas Tech University Health Sciences Center
Lubbock, Texas, United States
Sun Research Institute
San Antonio, Texas, United States
Advanced Research Institute
Ogden, Utah, United States
J. Lewis Research Inc., Foothills Family Clinic
Salt Lake City, Utah, United States
Charlottesville Medical Research
Charlottesville, Virginia, United States
New River Valley Research Institute
Christiansburg, Virginia, United States
National Clinical Research Inc
Richmond, Virginia, United States
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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ASMP2003
Identifier Type: -
Identifier Source: org_study_id