Phase 2
N=388
A Study of MD-7246 to Treat Abdominal Pain in Patients With Diarrhea-predominant Irritable Bowel Syndrome
Irritable Bowel Syndrome With Diarrhea (IBS-D)
Bottom Line
View on ClinicalTrials.gov: NCT03931785 ↗Enrolled (actual)
388
Serious AEs
0.3%
Results posted
Mar 2021
Primary outcome: Primary: Change From Baseline in Abdominal Pain at Its Worst on a NRS Through the Treatment Period — -2.01; -1.93; -1.58; -1.95 units on a scale — p=0.7467
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- MD-7246 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ironwood Pharmaceuticals, Inc.
- Primary completion
- Feb 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Abdominal Pain at Its Worst on a NRS Through the Treatment Period |
-2.01; -1.93; -1.58; -1.95 | 0.7467 |
| PRIMARY Percentage of Participants Who Were 6/12 Week Abdominal Pain 30% Change Responders |
55.7; 56.7; 44.3; 48.5 | 0.8852 |
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).
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03931785). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.