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

Phase 2

Completed

• Conditions: Irritable Bowel Syndrome With Diarrhea (IBS-D)
• Interventions: Drug: MD-7246; Drug: Placebo

• Registration Number: NCT03931785
• Lead Sponsor: Ironwood Pharmaceuticals, Inc.

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-22
• Study First Submitted QC: 2019-04-25
• Study First Posted: 2019-04-30
• Study Start: 2019-05-01
• Primary Completion: 2020-02-26
• Study Completion: 2020-03-11
• Status Verified: 2021-02
• Results First Submitted: 2021-02-19
• Results First Submitted QC: 2021-02-19
• Last Update Submitted: 2021-02-19
• Results First Posted: 2021-03-12
• Last Update Posted: 2021-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 515

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MD-7246 300 μg	Placebo	1 MD-7246 300-μg oral tablet and 3 matching placebo oral tablets
MD-7246 600 μg	MD-7246	2 MD-7246 300-μg oral tablets and 2 matching placebo oral tablets
MD-7246 600 μg	Placebo	2 MD-7246 300-μg oral tablets and 2 matching placebo oral tablets
Placebo	Placebo	4 matching placebo oral tablets
MD-7246 300 μg	MD-7246	1 MD-7246 300-μg oral tablet and 3 matching placebo oral tablets
MD-7246 1200 μg	MD-7246	4 MD-7246 300-μg oral tablets

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Abdominal Pain at Its Worst on a NRS Through the Treatment Period	Baseline, up to Week 12 (end of 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.
Percentage of Participants Who Were 6/12 Week Abdominal Pain 30% Change Responders	Baseline through Week 12	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.

Trial Locations

Locations (75)

Clinical Research Associates; 🇺🇸 Huntsville, Alabama, United States

Elite Clinical Studies; 🇺🇸 Phoenix, Arizona, United States

Arkansas Gastroenterology; 🇺🇸 North Little Rock, Arkansas, United States

GW Research, Inc.; 🇺🇸 Chula Vista, California, United States

Kindred Medical Institute for Clinical Trials, LLC; 🇺🇸 Corona, California, United States

Diagnamics Inc.; 🇺🇸 Encinitas, California, United States

St. Joseph Heritage Healthcare; 🇺🇸 Fullerton, California, United States

Paragon Rx Clinical; 🇺🇸 Garden Grove, California, United States

Grossmont Center For Clinical Research; 🇺🇸 La Mesa, California, United States

Facey Medical Foundation; 🇺🇸 Mission Hills, California, United States

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