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

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Ironwood Pharmaceuticals

Status and phase

Completed
Phase 2

Conditions

Irritable Bowel Syndrome With Diarrhea (IBS-D)

Treatments

Drug: MD-7246
Drug: Placebo

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:

  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

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

Trial documents
2

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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