A Study of MD-7246 to Treat Abdominal Pain in Patients With Diarrhea-predominant Irritable Bowel Syndrome
NCT ID: NCT03931785
Last Updated: 2021-03-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
515 participants
INTERVENTIONAL
2019-05-01
2020-03-11
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
DOUBLE
Study Groups
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MD-7246 300 μg
1 MD-7246 300-μg oral tablet and 3 matching placebo oral tablets
MD-7246
Oral tablet
Placebo
Matching oral tablet
MD-7246 600 μg
2 MD-7246 300-μg oral tablets and 2 matching placebo oral tablets
MD-7246
Oral tablet
Placebo
Matching oral tablet
MD-7246 1200 μg
4 MD-7246 300-μg oral tablets
MD-7246
Oral tablet
Placebo
4 matching placebo oral tablets
Placebo
Matching oral tablet
Interventions
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MD-7246
Oral tablet
Placebo
Matching oral tablet
Eligibility Criteria
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Inclusion Criteria
* Patient maintains a minimum level of compliance with daily diary
* Female patients of childbearing potential must agree to use one of the following methods of birth control:
1. Hormonal contraception
2. Double-barrier method
3. Maintenance of a monogamous relationship with a male partner who has been surgically sterilized by vasectomy
Exclusion Criteria
* Patient has symptoms of or been diagnosed with a medical condition that may contribute to abdominal pain
* Patient has a structural abnormality of the gastrointestinal (GI) tract or a disease or condition that can affect GI motility
* Patient has any protocol-excluded or clinically significant medical or surgical history that could confound the study assessments
18 Years
ALL
No
Sponsors
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Allergan Sales, LLC
INDUSTRY
Ironwood Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Wilmin Bartolini, PhD
Role: STUDY_CHAIR
Ironwood Pharmaceuticals, Inc.
Locations
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Clinical Research Associates
Huntsville, Alabama, United States
Elite Clinical Studies
Phoenix, Arizona, United States
Arkansas Gastroenterology
North Little Rock, Arkansas, United States
GW Research, Inc.
Chula Vista, California, United States
Kindred Medical Institute for Clinical Trials, LLC
Corona, California, United States
Diagnamics Inc.
Encinitas, California, United States
St. Joseph Heritage Healthcare
Fullerton, California, United States
Paragon Rx Clinical
Garden Grove, California, United States
Grossmont Center For Clinical Research
La Mesa, California, United States
Facey Medical Foundation
Mission Hills, California, United States
Providence Clinical Research
North Hollywood, California, United States
Precision Research Institute
San Diego, California, United States
Paragon Rx Clinical, Inc. - Santa Ana
Santa Ana, California, United States
UNISON Clinical Trials
Sherman Oaks, California, United States
Millennium Clinical Trials
Thousand Oaks, California, United States
Advanced Rx Clinical Research
Westminster, California, United States
Peak Gastroenterology Associates
Colorado Springs, Colorado, United States
Connecticut Clinical Research Institute
Bristol, Connecticut, United States
Chase Medical Research of Greater New Haven LLC
Hamden, Connecticut, United States
The Chappel Group Research, LLC
Kissimmee, Florida, United States
Well Pharma Medical Research Corporation
Miami, Florida, United States
New Horizon Research Center
Miami, Florida, United States
San Marcus Research Clinic Inc
Miami Lakes, Florida, United States
Ormond Medical Arts Pharmaceutical Research Center
Ormond Beach, Florida, United States
Meridien Research
St. Petersburg, Florida, United States
Palm Beach Research Center
West Palm Beach, Florida, United States
Research Institute of Central Florida, LLC
Winter Park, Florida, United States
Mount Vernon Clinical Research, LLC
Sandy Springs, Georgia, United States
Rockford Gastroenterology Associates LTD
Rockford, Illinois, United States
Clinical Trials Management LLC
Metairie, Louisiana, United States
Clinical Trials of America -- LA LLC
West Monroe, Louisiana, United States
Meritus Center For Clinical Research
Hagerstown, Maryland, United States
Meridian Clinical Research
Rockville, Maryland, United States
Boston Clinical Trials Inc
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
New England Center For Clinical Research Inc PrimaCare Research, LLC
Fall River, Massachusetts, United States
MedVadis Research Corporation
Watertown, Massachusetts, United States
Galen Research
Chesterfield, Missouri, United States
Bozeman Health Deaconess Hospital
Bozeman, Montana, United States
Barrett Clinic, P.C. - BTC - PPDS
La Vista, Nebraska, United States
Meridian Clinical Research
Omaha, Nebraska, United States
Clinical Research of South Nevada
Las Vegas, Nevada, United States
Advanced Biomedical Research of America
Las Vegas, Nevada, United States
Healthwise Medical Associates
Brooklyn, New York, United States
Long Island Gastrointestinal Research Group LLP
Great Neck, New York, United States
Rochester Clinical Research, Inc
Rochester, New York, United States
Carolina Digestive Health Associates
Charlotte, North Carolina, United States
Carolina Digestive Health Associates
Concord, North Carolina, United States
Peters Medical Research, LLC
High Point, North Carolina, United States
Clinical Trials of America-NC, LLC
Mount Airy, North Carolina, United States
M3 Wake Research, Inc
Raleigh, North Carolina, United States
PMG Research of Wilmington
Wilmington, North Carolina, United States
Lyndhurst Clinical Research
Winston-Salem, North Carolina, United States
PMG Research of Winston-Salem
Winston-Salem, North Carolina, United States
Progressive Medicine of the Triad, LLC
Winston-Salem, North Carolina, United States
Lillestol Research
Fargo, North Dakota, United States
Hometown Urgent Care and Research
Cincinnati, Ohio, United States
Hightop Medical Research Center
Cincinnati, Ohio, United States
New Horizons Clinical Research
Cincinnati, Ohio, United States
Hometown Urgent Care and Research
Columbus, Ohio, United States
Remington Davis Inc
Columbus, Ohio, United States
Hometown Urgent Care and Research
Dayton, Ohio, United States
Central Sooner Research
Norman, Oklahoma, United States
IPS Research Company
Oklahoma City, Oklahoma, United States
Digestive Disease Specialists, Inc.
Oklahoma City, Oklahoma, United States
Oregon Center For Clinical Investigations Inc
Salem, Oregon, United States
Partners In Clinical Research
Cumberland, Rhode Island, United States
Ocean State Clinical Research Partners
Lincoln, Rhode Island, United States
Mountain View Clinical Research Inc
Greer, South Carolina, United States
WR-ClinSearch, LLC
Chattanooga, Tennessee, United States
New Phase Research & Development
Knoxville, Tennessee, United States
MW Clinical Research Center
Beaumont, Texas, United States
Texas Tech University Health Sciences Center
El Paso, Texas, United States
Southwest Clinical Trials
Houston, Texas, United States
Southwest Clinical Trials
Houston, Texas, United States
Quality Research Inc
San Antonio, Texas, United States
Diagnostics Research Group
San Antonio, Texas, United States
DCT - Stone Oak, LLC dba Discovery Clinical Trials
San Antonio, Texas, United States
Advanced Research Institute
Ogden, Utah, United States
New River Valley Research Institute
Christiansburg, Virginia, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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MCP-103-205
Identifier Type: -
Identifier Source: org_study_id
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