A Study of MD-7246 to Treat Abdominal Pain in Patients With Diarrhea-predominant Irritable Bowel Syndrome

• Status: Completed
• Trial end date: 2020-03-11
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ironwood Pharmaceuticals, Inc.
• Collaborator: Allergan Sales, LLC

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:

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 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