A Study of MD-7246 to Treat Abdominal Pain in Patients With Diarrhea-predominant Irritable Bowel Syndrome
A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-range-finding Study of MD-7246 Administered Orally for 12 Weeks to Treat Abdominal Pain in Patients With Diarrhea-predominant Irritable Bowel Syndrome
1 other identifier
interventional
515
1 country
80
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2019
Shorter than P25 for phase_2
80 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 22, 2019
CompletedFirst Posted
Study publicly available on registry
April 30, 2019
CompletedStudy Start
First participant enrolled
May 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 26, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 11, 2020
CompletedResults Posted
Study results publicly available
March 12, 2021
CompletedMarch 12, 2021
February 1, 2021
10 months
April 22, 2019
February 19, 2021
February 19, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change From Baseline in Abdominal Pain at Its Worst on a NRS Through 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.
Baseline, up to Week 12 (end of the Treatment Period)
Percentage of Participants Who Were 6/12 Week Abdominal Pain 30% Change Responders
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.
Baseline through Week 12
Study Arms (4)
MD-7246 300 μg
EXPERIMENTAL1 MD-7246 300-μg oral tablet and 3 matching placebo oral tablets
MD-7246 600 μg
EXPERIMENTAL2 MD-7246 300-μg oral tablets and 2 matching placebo oral tablets
MD-7246 1200 μg
EXPERIMENTAL4 MD-7246 300-μg oral tablets
Placebo
PLACEBO COMPARATOR4 matching placebo oral tablets
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ironwood Pharmaceuticals, Inc.lead
- Allergan Sales, LLCcollaborator
Study Sites (80)
Clinical Research Associates
Huntsville, Alabama, 35801, United States
Elite Clinical Studies
Phoenix, Arizona, 85018, United States
Arkansas Gastroenterology
North Little Rock, Arkansas, 72117, United States
GW Research, Inc.
Chula Vista, California, 91910, United States
Kindred Medical Institute for Clinical Trials, LLC
Corona, California, 92879, United States
Diagnamics Inc.
Encinitas, California, 92024, United States
St. Joseph Heritage Healthcare
Fullerton, California, 92835, United States
Paragon Rx Clinical
Garden Grove, California, 92840, United States
Grossmont Center For Clinical Research
La Mesa, California, 91942, United States
Facey Medical Foundation
Mission Hills, California, 91345, United States
Providence Clinical Research
North Hollywood, California, 91606, United States
Precision Research Institute
San Diego, California, 92114, United States
Paragon Rx Clinical, Inc. - Santa Ana
Santa Ana, California, 92703, United States
UNISON Clinical Trials
Sherman Oaks, California, 91403, United States
Millennium Clinical Trials
Thousand Oaks, California, 91360, United States
Advanced Rx Clinical Research
Westminster, California, 92683, United States
Peak Gastroenterology Associates
Colorado Springs, Colorado, 80907, United States
Connecticut Clinical Research Institute
Bristol, Connecticut, 06010, United States
Chase Medical Research of Greater New Haven LLC
Hamden, Connecticut, 06517, United States
The Chappel Group Research, LLC
Kissimmee, Florida, 34744, United States
Well Pharma Medical Research Corporation
Miami, Florida, 33143, United States
New Horizon Research Center
Miami, Florida, 33175, United States
San Marcus Research Clinic Inc
Miami Lakes, Florida, 33014, United States
Ormond Medical Arts Pharmaceutical Research Center
Ormond Beach, Florida, 32174, United States
Meridien Research
St. Petersburg, Florida, 33709, United States
Palm Beach Research Center
West Palm Beach, Florida, 33409, United States
Research Institute of Central Florida, LLC
Winter Park, Florida, 32792, United States
Mount Vernon Clinical Research, LLC
Sandy Springs, Georgia, 30328, United States
Rockford Gastroenterology Associates LTD
Rockford, Illinois, 61107, United States
Clinical Trials Management LLC
Metairie, Louisiana, 70006, United States
Clinical Trials of America -- LA LLC
West Monroe, Louisiana, 71291, United States
Meritus Center For Clinical Research
Hagerstown, Maryland, 21742, United States
Meridian Clinical Research
Rockville, Maryland, 20854, United States
Boston Clinical Trials Inc
Boston, Massachusetts, 02131, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
New England Center For Clinical Research Inc PrimaCare Research, LLC
Fall River, Massachusetts, 02721, United States
MedVadis Research Corporation
Watertown, Massachusetts, 02472, United States
Galen Research
Chesterfield, Missouri, 63005, United States
Bozeman Health Deaconess Hospital
Bozeman, Montana, 59718, United States
Barrett Clinic, P.C. - BTC - PPDS
La Vista, Nebraska, 68128, United States
Meridian Clinical Research
Omaha, Nebraska, 68134, United States
Clinical Research of South Nevada
Las Vegas, Nevada, 89121, United States
Advanced Biomedical Research of America
Las Vegas, Nevada, 89123, United States
Healthwise Medical Associates
Brooklyn, New York, 11206, United States
Long Island Gastrointestinal Research Group LLP
Great Neck, New York, 11023, United States
Rochester Clinical Research, Inc
Rochester, New York, 14609, United States
Carolina Digestive Health Associates
Charlotte, North Carolina, 28210, United States
Carolina Digestive Health Associates
Concord, North Carolina, 28025, United States
Peters Medical Research, LLC
High Point, North Carolina, 27262, United States
Clinical Trials of America-NC, LLC
Mount Airy, North Carolina, 27030, United States
M3 Wake Research, Inc
Raleigh, North Carolina, 43212, United States
PMG Research of Wilmington
Wilmington, North Carolina, 28401, United States
Lyndhurst Clinical Research
Winston-Salem, North Carolina, 27103, United States
PMG Research of Winston-Salem
Winston-Salem, North Carolina, 27103, United States
Progressive Medicine of the Triad, LLC
Winston-Salem, North Carolina, 27103, United States
Lillestol Research
Fargo, North Dakota, 58104, United States
Hometown Urgent Care and Research
Cincinnati, Ohio, 45215, United States
Hightop Medical Research Center
Cincinnati, Ohio, 45224, United States
New Horizons Clinical Research
Cincinnati, Ohio, 45242, United States
Hometown Urgent Care and Research
Columbus, Ohio, 42314, United States
Remington Davis Inc
Columbus, Ohio, 43215, United States
Hometown Urgent Care and Research
Dayton, Ohio, 45424, United States
Central Sooner Research
Norman, Oklahoma, 73071, United States
IPS Research Company
Oklahoma City, Oklahoma, 73106, United States
Digestive Disease Specialists, Inc.
Oklahoma City, Oklahoma, 73112, United States
Oregon Center For Clinical Investigations Inc
Salem, Oregon, 97301, United States
Partners In Clinical Research
Cumberland, Rhode Island, 02864, United States
Ocean State Clinical Research Partners
Lincoln, Rhode Island, 02865, United States
Mountain View Clinical Research Inc
Greer, South Carolina, 29651, United States
WR-ClinSearch, LLC
Chattanooga, Tennessee, 37421, United States
New Phase Research & Development
Knoxville, Tennessee, 37909, United States
MW Clinical Research Center
Beaumont, Texas, 77701, United States
Texas Tech University Health Sciences Center
El Paso, Texas, 79905-2709, United States
Southwest Clinical Trials
Houston, Texas, 77074, United States
Southwest Clinical Trials
Houston, Texas, 77081, United States
Quality Research Inc
San Antonio, Texas, 78209, United States
Diagnostics Research Group
San Antonio, Texas, 78229, United States
DCT - Stone Oak, LLC dba Discovery Clinical Trials
San Antonio, Texas, 78258, United States
Advanced Research Institute
Ogden, Utah, 84405, United States
New River Valley Research Institute
Christiansburg, Virginia, 24073, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Wilmin Bartolini, Ph.D.
- Organization
- Ironwood Pharmaceuticals, Inc.
Study Officials
- STUDY CHAIR
Wilmin Bartolini, PhD
Ironwood Pharmaceuticals, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 22, 2019
First Posted
April 30, 2019
Study Start
May 1, 2019
Primary Completion
February 26, 2020
Study Completion
March 11, 2020
Last Updated
March 12, 2021
Results First Posted
March 12, 2021
Record last verified: 2021-02