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

Ironwood Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Irritable Bowel Syndrome With Diarrhea (IBS-D)

Treatments: Drug: Placebo; Drug: MD-7246

Study type: Interventional

Funder types: Industry

Identifiers

NCT03931785

MCP-103-205

Details and patient eligibility

About

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).

Enrollment: 515 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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515 participants in 4 patient groups, including a placebo group

MD-7246 300 μg

Experimental group

Description:

1 MD-7246 300-μg oral tablet and 3 matching placebo oral tablets

Treatment:

Drug: Placebo

Drug: MD-7246

MD-7246 600 μg

Experimental group

Description:

2 MD-7246 300-μg oral tablets and 2 matching placebo oral tablets

Treatment:

Drug: Placebo

Drug: MD-7246

MD-7246 1200 μg

Experimental group

Description:

4 MD-7246 300-μg oral tablets

Treatment:

Drug: MD-7246

Placebo

Placebo Comparator group

Description:

4 matching placebo oral tablets

Treatment:

Drug: Placebo