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Completed

NCT Number: NCT03931785

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

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).

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Key information

Conditions

Irritable Bowel Syndrome With Diarrhea (IBS-D) Abdominal Pain Colonic Diseases Colonic Diseases, Functional Diarrhea Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Irritable Bowel Syndrome Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Clinical Research Associates, Huntsville, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MD-7246

Drug

Oral tablet

Placebo

Drug

Matching oral tablet

Primary outcomes

  1. Change From Baseline in Abdominal Pain at Its Worst on a NRS Through the Treatment Period

    Time frame: 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.

  2. Percentage of Participants Who Were 6/12 Week Abdominal Pain 30% Change Responders

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ironwood Pharmaceuticals, Inc.

Industry

Collaborators

  • Allergan Sales, LLC

Registry information

Official study title

A Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-range-finding Study of MD-7246 Administered Orally for 12 Weeks to Treat Abdominal Pain in Patients With Diarrhea-predominant Irritable Bowel Syndrome

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 30, 2019
Registry last updated
Mar 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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