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

Irritable Bowel Syndrome With Diarrhea (IBS-D) Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03931785
• Other study ID #: MCP-103-205
• Status: Completed
• Phase: Phase 2
• Start date: May 1, 2019
• Est. completion date: March 11, 2020

Study information

• Verified date: February 2021
• Source: Ironwood Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 515
• Est. completion date: March 11, 2020
• Est. primary completion date: February 26, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Abdominal Pain
• Diarrhea
• Irritable Bowel Syndrome
• Irritable Bowel Syndrome With Diarrhea (IBS-D)
• Syndrome

Intervention

Drug:
• MD-7246
Oral tablet
• Placebo
Matching oral tablet

Locations

Country	Name	City	State
United States	MW Clinical Research Center	Beaumont	Texas
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Boston Clinical Trials Inc	Boston	Massachusetts
United States	Bozeman Health Deaconess Hospital	Bozeman	Montana
United States	Connecticut Clinical Research Institute	Bristol	Connecticut
United States	Healthwise Medical Associates	Brooklyn	New York
United States	Carolina Digestive Health Associates	Charlotte	North Carolina
United States	WR-ClinSearch, LLC	Chattanooga	Tennessee
United States	Galen Research	Chesterfield	Missouri
United States	New River Valley Research Institute	Christiansburg	Virginia
United States	GW Research, Inc.	Chula Vista	California
United States	Hightop Medical Research Center	Cincinnati	Ohio
United States	Hometown Urgent Care and Research	Cincinnati	Ohio
United States	New Horizons Clinical Research	Cincinnati	Ohio
United States	Peak Gastroenterology Associates	Colorado Springs	Colorado
United States	Hometown Urgent Care and Research	Columbus	Ohio
United States	Remington Davis Inc	Columbus	Ohio
United States	Carolina Digestive Health Associates	Concord	North Carolina
United States	Kindred Medical Institute for Clinical Trials, LLC	Corona	California
United States	Partners In Clinical Research	Cumberland	Rhode Island
United States	Hometown Urgent Care and Research	Dayton	Ohio
United States	Texas Tech University Health Sciences Center	El Paso	Texas
United States	Diagnamics Inc.	Encinitas	California
United States	New England Center For Clinical Research Inc PrimaCare Research, LLC	Fall River	Massachusetts
United States	Lillestol Research	Fargo	North Dakota
United States	St. Joseph Heritage Healthcare	Fullerton	California
United States	Paragon Rx Clinical	Garden Grove	California
United States	Long Island Gastrointestinal Research Group LLP	Great Neck	New York
United States	Mountain View Clinical Research Inc	Greer	South Carolina
United States	Meritus Center For Clinical Research	Hagerstown	Maryland
United States	Chase Medical Research of Greater New Haven LLC	Hamden	Connecticut
United States	Peters Medical Research, LLC	High Point	North Carolina
United States	Southwest Clinical Trials	Houston	Texas
United States	Southwest Clinical Trials	Houston	Texas
United States	Clinical Research Associates	Huntsville	Alabama
United States	The Chappel Group Research, LLC	Kissimmee	Florida
United States	New Phase Research & Development	Knoxville	Tennessee
United States	Grossmont Center For Clinical Research	La Mesa	California
United States	Barrett Clinic, P.C. - BTC - PPDS	La Vista	Nebraska
United States	Advanced Biomedical Research of America	Las Vegas	Nevada
United States	Clinical Research of South Nevada	Las Vegas	Nevada
United States	Ocean State Clinical Research Partners	Lincoln	Rhode Island
United States	Clinical Trials Management LLC	Metairie	Louisiana
United States	New Horizon Research Center	Miami	Florida
United States	Well Pharma Medical Research Corporation	Miami	Florida
United States	San Marcus Research Clinic Inc	Miami Lakes	Florida
United States	Facey Medical Foundation	Mission Hills	California
United States	Clinical Trials of America-NC, LLC	Mount Airy	North Carolina
United States	Central Sooner Research	Norman	Oklahoma
United States	Providence Clinical Research	North Hollywood	California
United States	Arkansas Gastroenterology	North Little Rock	Arkansas
United States	Advanced Research Institute	Ogden	Utah
United States	Digestive Disease Specialists, Inc.	Oklahoma City	Oklahoma
United States	IPS Research Company	Oklahoma City	Oklahoma
United States	Meridian Clinical Research	Omaha	Nebraska
United States	Ormond Medical Arts Pharmaceutical Research Center	Ormond Beach	Florida
United States	Elite Clinical Studies	Phoenix	Arizona
United States	M3 Wake Research, Inc	Raleigh	North Carolina
United States	Rochester Clinical Research, Inc	Rochester	New York
United States	Rockford Gastroenterology Associates LTD	Rockford	Illinois
United States	Meridian Clinical Research	Rockville	Maryland
United States	Meridien Research	Saint Petersburg	Florida
United States	Oregon Center For Clinical Investigations Inc	Salem	Oregon
United States	DCT - Stone Oak, LLC dba Discovery Clinical Trials	San Antonio	Texas
United States	Diagnostics Research Group	San Antonio	Texas
United States	Quality Research Inc	San Antonio	Texas
United States	Precision Research Institute	San Diego	California
United States	Mount Vernon Clinical Research, LLC	Sandy Springs	Georgia
United States	Paragon Rx Clinical, Inc. - Santa Ana	Santa Ana	California
United States	UNISON Clinical Trials	Sherman Oaks	California
United States	Millennium Clinical Trials	Thousand Oaks	California
United States	MedVadis Research Corporation	Watertown	Massachusetts
United States	Clinical Trials of America -- LA LLC	West Monroe	Louisiana
United States	Palm Beach Research Center	West Palm Beach	Florida
United States	Advanced Rx Clinical Research	Westminster	California
United States	PMG Research of Wilmington	Wilmington	North Carolina
United States	Lyndhurst Clinical Research	Winston-Salem	North Carolina
United States	PMG Research of Winston-Salem	Winston-Salem	North Carolina
United States	Progressive Medicine of the Triad, LLC	Winston-Salem	North Carolina
United States	Research Institute of Central Florida, LLC	Winter Park	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Ironwood Pharmaceuticals, Inc.	Allergan Sales, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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