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

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

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).

Study Overview

• Status: Completed
• Conditions: Irritable Bowel Syndrome With Diarrhea (IBS-D)
• Intervention / Treatment: Drug: Placebo; Drug: MD-7246

• Study Type: Interventional
• Enrollment (Actual): 515
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Huntsville, Alabama, United States, 35801
      • Clinical Research Associates
  • Arizona
    • Phoenix, Arizona, United States, 85018
      • Elite Clinical Studies
  • Arkansas
    • North Little Rock, Arkansas, United States, 72117
      • Arkansas Gastroenterology
  • California
    • Chula Vista, California, United States, 91910
      • GW Research, Inc.
    • Corona, California, United States, 92879
      • Kindred Medical Institute for Clinical Trials, LLC
    • Encinitas, California, United States, 92024
      • Diagnamics Inc.
    • Fullerton, California, United States, 92835
      • St. Joseph Heritage Healthcare
    • Garden Grove, California, United States, 92840
      • Paragon Rx Clinical
    • La Mesa, California, United States, 91942
      • Grossmont Center for Clinical Research
    • Mission Hills, California, United States, 91345
      • Facey Medical Foundation
    • North Hollywood, California, United States, 91606
      • Providence Clinical Research
    • San Diego, California, United States, 92114
      • Precision Research Institute
    • Santa Ana, California, United States, 92703
      • Paragon Rx Clinical, Inc. - Santa Ana
    • Sherman Oaks, California, United States, 91403
      • Unison Clinical Trials
    • Thousand Oaks, California, United States, 91360
      • Millennium Clinical Trials
    • Westminster, California, United States, 92683
      • Advanced Rx Clinical Research
  • Colorado
    • Colorado Springs, Colorado, United States, 80907
      • Peak Gastroenterology Associates
  • Connecticut
    • Bristol, Connecticut, United States, 06010
      • Connecticut Clinical Research Institute
    • Hamden, Connecticut, United States, 06517
      • Chase Medical Research of Greater New Haven LLC
  • Florida
    • Kissimmee, Florida, United States, 34744
      • The Chappel Group Research, LLC
    • Miami, Florida, United States, 33175
      • New Horizon Research Center
    • Miami, Florida, United States, 33143
      • Well Pharma Medical Research Corporation
    • Miami Lakes, Florida, United States, 33014
      • San Marcus Research Clinic Inc
    • Ormond Beach, Florida, United States, 32174
      • Ormond Medical Arts Pharmaceutical Research Center
    • Saint Petersburg, Florida, United States, 33709
      • Meridien Research
    • West Palm Beach, Florida, United States, 33409
      • Palm Beach Research center
    • Winter Park, Florida, United States, 32792
      • Research Institute of Central Florida, LLC
  • Georgia
    • Sandy Springs, Georgia, United States, 30328
      • Mount Vernon Clinical Research, LLC
  • Illinois
    • Rockford, Illinois, United States, 61107
      • Rockford Gastroenterology Associates LTD
  • Louisiana
    • Metairie, Louisiana, United States, 70006
      • Clinical Trials Management LLC
    • West Monroe, Louisiana, United States, 71291
      • Clinical Trials of America -- LA LLC
  • Maryland
    • Hagerstown, Maryland, United States, 21742
      • Meritus Center for Clinical Research
    • Rockville, Maryland, United States, 20854
      • Meridian Clinical Research
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
    • Boston, Massachusetts, United States, 02131
      • Boston Clinical Trials Inc
    • Fall River, Massachusetts, United States, 02721
      • New England Center For Clinical Research Inc PrimaCare Research, LLC
    • Watertown, Massachusetts, United States, 02472
      • MedVadis Research Corporation
  • Missouri
    • Chesterfield, Missouri, United States, 63005
      • Galen Research
  • Montana
    • Bozeman, Montana, United States, 59718
      • Bozeman Health Deaconess Hospital
  • Nebraska
    • La Vista, Nebraska, United States, 68128
      • Barrett Clinic, P.C. - BTC - PPDS
    • Omaha, Nebraska, United States, 68134
      • Meridian Clinical Research
  • Nevada
    • Las Vegas, Nevada, United States, 89121
      • Clinical Research of South Nevada
    • Las Vegas, Nevada, United States, 89123
      • Advanced Biomedical Research of America
  • New York
    • Brooklyn, New York, United States, 11206
      • Healthwise Medical Associates
    • Great Neck, New York, United States, 11023
      • Long Island Gastrointestinal Research Group LLP
    • Rochester, New York, United States, 14609
      • Rochester Clinical Research, Inc
  • North Carolina
    • Charlotte, North Carolina, United States, 28210
      • Carolina Digestive Health Associates
    • Concord, North Carolina, United States, 28025
      • Carolina Digestive Health Associates
    • High Point, North Carolina, United States, 27262
      • Peters Medical Research, LLC
    • Mount Airy, North Carolina, United States, 27030
      • Clinical Trials of America-NC, LLC
    • Raleigh, North Carolina, United States, 43212
      • M3 Wake Research, Inc
    • Wilmington, North Carolina, United States, 28401
      • PMG Research of Wilmington
    • Winston-Salem, North Carolina, United States, 27103
      • Progressive Medicine of the Triad, LLC
    • Winston-Salem, North Carolina, United States, 27103
      • Lyndhurst Clinical Research
    • Winston-Salem, North Carolina, United States, 27103
      • PMG Research of Winston-Salem
  • North Dakota
    • Fargo, North Dakota, United States, 58104
      • Lillestol Research
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • New Horizons Clinical Research
    • Cincinnati, Ohio, United States, 45224
      • Hightop Medical Research Center
    • Cincinnati, Ohio, United States, 45215
      • Hometown Urgent Care and Research
    • Columbus, Ohio, United States, 43215
      • Remington Davis Inc
    • Columbus, Ohio, United States, 42314
      • Hometown Urgent Care and Research
    • Dayton, Ohio, United States, 45424
      • Hometown Urgent Care and Research
  • Oklahoma
    • Norman, Oklahoma, United States, 73071
      • Central Sooner Research
    • Oklahoma City, Oklahoma, United States, 73112
      • Digestive Disease Specialists, Inc.
    • Oklahoma City, Oklahoma, United States, 73106
      • IPS Research Company
  • Oregon
    • Salem, Oregon, United States, 97301
      • Oregon Center for Clinical Investigations Inc
  • Rhode Island
    • Cumberland, Rhode Island, United States, 02864
      • Partners in Clinical Research
    • Lincoln, Rhode Island, United States, 02865
      • Ocean State Clinical Research Partners
  • South Carolina
    • Greer, South Carolina, United States, 29651
      • Mountain View Clinical Research Inc
  • Tennessee
    • Chattanooga, Tennessee, United States, 37421
      • WR-ClinSearch, LLC
    • Knoxville, Tennessee, United States, 37909
      • New Phase Research & Development
  • Texas
    • Beaumont, Texas, United States, 77701
      • MW Clinical Research Center
    • El Paso, Texas, United States, 79905-2709
      • Texas Tech University Health Sciences Center
    • Houston, Texas, United States, 77074
      • Southwest Clinical Trials
    • Houston, Texas, United States, 77081
      • Southwest Clinical Trials
    • San Antonio, Texas, United States, 78229
      • Diagnostics Research Group
    • San Antonio, Texas, United States, 78209
      • Quality Research Inc
    • San Antonio, Texas, United States, 78258
      • DCT - Stone Oak, LLC dba Discovery Clinical Trials
  • Utah
    • Ogden, Utah, United States, 84405
      • Advanced Research Institute
  • Virginia
    • Christiansburg, Virginia, United States, 24073
      • New River Valley Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: MD-7246 300 μg; 1 MD-7246 300-μg oral tablet and 3 matching placebo oral tablets	Drug: Placebo; Matching oral tablet; Drug: MD-7246; Oral tablet
EXPERIMENTAL: MD-7246 600 μg; 2 MD-7246 300-μg oral tablets and 2 matching placebo oral tablets	Drug: Placebo; Matching oral tablet; Drug: MD-7246; Oral tablet
EXPERIMENTAL: MD-7246 1200 μg; 4 MD-7246 300-μg oral tablets	Drug: MD-7246; Oral tablet
PLACEBO_COMPARATOR: Placebo; 4 matching placebo oral tablets	Drug: Placebo; Matching oral tablet

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ironwood Pharmaceuticals, Inc.
• Collaborators: Allergan Sales, LLC

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2019
• Primary Completion (ACTUAL): February 26, 2020
• Study Completion (ACTUAL): March 11, 2020

Study Registration Dates

• First Submitted: April 22, 2019
• First Submitted That Met QC Criteria: April 25, 2019
• First Posted (ACTUAL): April 30, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 12, 2021
• Last Update Submitted That Met QC Criteria: February 19, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Irritable Bowel Syndrome; Diarrhea; Abdominal pain
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Pain; Neurologic Manifestations; Disease; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome; Diarrhea; Abdominal Pain
• Other Study ID Numbers: MCP-103-205

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No