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

Completed · Phase 2 · Has a placebo group

Conditions studied: Irritable Bowel Syndrome With Diarrhea (IBS-D)

In brief

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).

Key facts

Study ID

NCT03931785

Run by

Ironwood Pharmaceuticals, Inc.

People needed

515

Starts

2019-05-01

Expected to finish

2020-03-11

Last updated by the study team

2021-03-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• Providence Clinical Research — North Hollywood, California, United States
• Precision Research Institute — San Diego, California, 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
• Advanced Rx Clinical Research — Westminster, California, United States
• Peak Gastroenterology Associates — Colorado Springs, Colorado, United States
• Connecticut Clinical Research Institute — Bristol, Connecticut, United States
• Chase Medical Research of Greater New Haven LLC — Hamden, Connecticut, United States
• The Chappel Group Research, LLC — Kissimmee, Florida, United States
• Well Pharma Medical Research Corporation — Miami, Florida, United States
• New Horizon Research Center — Miami, Florida, United States
• San Marcus Research Clinic Inc — Miami Lakes, Florida, United States
• Ormond Medical Arts Pharmaceutical Research Center — Ormond Beach, Florida, United States
• Meridien Research — St. Petersburg, Florida, United States
• Clinical Research Associates — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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