A Study of MD-7246 to Treat Abdominal Pain in Patients With Diarrhea-predominant Irritable Bowel Syndrome
- Conditions
- Irritable Bowel Syndrome With Diarrhea (IBS-D)
- Interventions
- Drug: MD-7246Drug: Placebo
- Registration Number
- NCT03931785
- Lead Sponsor
- Ironwood Pharmaceuticals, Inc.
- Brief Summary
To evaluate the safety and tolerability, treatment effect on abdominal pain, and dose response of MD-7246 administered orally to patients with diarrhea-predominant irritable bowel syndrome (IBS-D).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 515
-
Patient meets the Rome IV criteria for diagnosis of IBS-D
-
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:
- Hormonal contraception
- Double-barrier method
- Maintenance of a monogamous relationship with a male partner who has been surgically sterilized by vasectomy
- Patient has clinically significant findings on a physical examination and/or clinical laboratory tests
- 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
NOTE: Additional inclusion/exclusion criteria may apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MD-7246 300 μg Placebo 1 MD-7246 300-μg oral tablet and 3 matching placebo oral tablets MD-7246 600 μg MD-7246 2 MD-7246 300-μg oral tablets and 2 matching placebo oral tablets MD-7246 600 μg Placebo 2 MD-7246 300-μg oral tablets and 2 matching placebo oral tablets Placebo Placebo 4 matching placebo oral tablets MD-7246 300 μg MD-7246 1 MD-7246 300-μg oral tablet and 3 matching placebo oral tablets MD-7246 1200 μg MD-7246 4 MD-7246 300-μg oral tablets
- Primary Outcome Measures
Name Time Method Change From Baseline in Abdominal Pain at Its Worst on a NRS Through the Treatment Period Baseline, up to Week 12 (end of the Treatment Period) Abdominal pain is measured daily in an eDiary, using an 11-point NRS, where 0 is anchored with "no abdominal pain" and 10 is anchored with "worst possible abdominal pain." The postbaseline weekly abdominal pain score is the average of the non-missing daily abdominal pain at its worst scores during a week (Weeks 1-12) if there are at least 4 daily scores entered into the eDiary during the week. Weekly change from baseline was calculated for each week as the weekly score minus the baseline score.
Mixed model repeated measures (MMRM) results are based on a repeated measures analysis with treatment, analysis week, and treatment-by-week interaction as fixed effects and baseline as covariate. An unstructured covariance structure was used to model intra-subject correlation with subjects as a random effect.
Baseline is derived from the eDiary data collected daily in the Pretreatment Period, specifically the period of time from 14 days before randomization up to the time of randomization.Percentage of Participants Who Were 6/12 Week Abdominal Pain 30% Change Responders Baseline through Week 12 A 6/12 Week Abdominal Pain 30% Responder was a participant who had a decrease from baseline of ≥30% in the weekly abdominal pain score for that week for at least 6 out of the 12 weeks of the Treatment Period; for any week, a participant with \< 4 daily abdominal pain scores available was considered a non-responder for that week.
Abdominal pain is measured daily in an eDiary, using an 11-point NRS, where 0 is anchored with "no abdominal pain" and 10 is anchored with "worst possible abdominal pain." The postbaseline weekly abdominal pain score is the average of the non-missing daily abdominal pain at its worst scores during a week (Weeks 1-12) if there are at least 4 daily scores entered into the eDiary during the week.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (75)
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Barrett Clinic, P.C. - BTC - PPDS
🇺🇸La Vista, Nebraska, United States
New Phase Research & Development
🇺🇸Knoxville, Tennessee, United States
Connecticut Clinical Research Institute
🇺🇸Bristol, Connecticut, United States
Meridien Research
🇺🇸Saint 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
New England Center For Clinical Research Inc PrimaCare Research, LLC
🇺🇸Fall River, Massachusetts, United States
Peak Gastroenterology Associates
🇺🇸Colorado Springs, Colorado, United States
Lillestol Research
🇺🇸Fargo, North Dakota, United States
Well Pharma Medical Research Corporation
🇺🇸Miami, Florida, United States
IPS Research Company
🇺🇸Oklahoma City, Oklahoma, United States
Meridian Clinical Research
🇺🇸Omaha, Nebraska, United States
Clinical Research Associates
🇺🇸Huntsville, Alabama, United States
Elite Clinical Studies
🇺🇸Phoenix, Arizona, United States
Arkansas Gastroenterology
🇺🇸North Little Rock, Arkansas, United States
Diagnamics Inc.
🇺🇸Encinitas, California, United States
Kindred Medical Institute for Clinical Trials, LLC
🇺🇸Corona, California, United States
GW Research, Inc.
🇺🇸Chula Vista, California, United States
St. Joseph Heritage Healthcare
🇺🇸Fullerton, California, United States
Paragon Rx Clinical
🇺🇸Garden Grove, California, United States
Facey Medical Foundation
🇺🇸Mission Hills, California, United States
Precision Research Institute
🇺🇸San Diego, California, United States
Providence Clinical Research
🇺🇸North Hollywood, California, United States
Grossmont Center For Clinical Research
🇺🇸La Mesa, 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
Chase Medical Research of Greater New Haven LLC
🇺🇸Hamden, Connecticut, United States
The Chappel Group Research, LLC
🇺🇸Kissimmee, Florida, United States
San Marcus Research Clinic Inc
🇺🇸Miami Lakes, Florida, United States
New Horizon Research Center
🇺🇸Miami, Florida, United States
Ormond Medical Arts Pharmaceutical Research Center
🇺🇸Ormond Beach, Florida, United States
Clinical Trials Management LLC
🇺🇸Metairie, Louisiana, United States
Mount Vernon Clinical Research, LLC
🇺🇸Sandy Springs, Georgia, United States
Rockford Gastroenterology Associates LTD
🇺🇸Rockford, Illinois, United States
Meritus Center For Clinical Research
🇺🇸Hagerstown, Maryland, United States
Clinical Trials of America -- LA LLC
🇺🇸West Monroe, Louisiana, United States
Boston Clinical Trials Inc
🇺🇸Boston, Massachusetts, United States
MedVadis Research Corporation
🇺🇸Watertown, Massachusetts, United States
Clinical Research of South Nevada
🇺🇸Las Vegas, Nevada, United States
Galen Research
🇺🇸Chesterfield, Missouri, United States
Bozeman Health Deaconess Hospital
🇺🇸Bozeman, Montana, United States
Healthwise Medical Associates
🇺🇸Brooklyn, New York, United States
Advanced Biomedical Research of America
🇺🇸Las Vegas, Nevada, United States
Long Island Gastrointestinal Research Group LLP
🇺🇸Great Neck, New York, United States
Rochester Clinical Research, Inc
🇺🇸Rochester, New York, United States
Peters Medical Research, LLC
🇺🇸High Point, North Carolina, United States
Carolina Digestive Health Associates
🇺🇸Concord, North Carolina, United States
M3 Wake Research, Inc
🇺🇸Raleigh, North Carolina, United States
Clinical Trials of America-NC, LLC
🇺🇸Mount Airy, North Carolina, United States
PMG Research of Wilmington
🇺🇸Wilmington, North Carolina, United States
Hometown Urgent Care and Research
🇺🇸Dayton, Ohio, United States
Remington Davis Inc
🇺🇸Columbus, Ohio, United States
Hightop Medical Research Center
🇺🇸Cincinnati, Ohio, United States
New Horizons Clinical Research
🇺🇸Cincinnati, Ohio, United States
Central Sooner Research
🇺🇸Norman, 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
MW Clinical Research Center
🇺🇸Beaumont, Texas, United States
WR-ClinSearch, LLC
🇺🇸Chattanooga, Tennessee, United States
Diagnostics Research Group
🇺🇸San Antonio, Texas, United States
New River Valley Research Institute
🇺🇸Christiansburg, Virginia, United States
Quality Research Inc
🇺🇸San Antonio, Texas, United States
Texas Tech University Health Sciences Center
🇺🇸El Paso, Texas, United States
Advanced Research Institute
🇺🇸Ogden, Utah, United States
Southwest Clinical Trials
🇺🇸Houston, Texas, United States
DCT - Stone Oak, LLC dba Discovery Clinical Trials
🇺🇸San Antonio, Texas, 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