The Plecanatide Irritable Bowel Syndrome With Constipation Study (IBS-C)

• Status: Completed
• Trial end date: 2017-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This study in patients with IBS-C is a randomized, double-blind, placebo-controlled, parallel-group clinical trial with 12 weeks of study drug therapy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bausch Health Americas, Inc.; Synergy Pharmaceuticals Inc.
• Treatments: Plecanatide

Criteria

Inclusion Criteria:

•Adult patients between the ages of 18 and 85 years (inclusive) with a diagnosis of IBS based on ROME III diagnostic criteria and meeting criteria for diagnosis of the constipation predominant subtype - IBS-C

Exclusion Criteria:

• Refusal or inability to sign informed consent for the trial

• Refusal or inability to complete daily Episodic (real-time) BM / RM calls, End of Day daily Calls, and/or complete electronic questionnaires

• BMI > 35 or < 18

• Women of child bearing potential who refuse to use an acceptable method of birth control for the duration of the trial

• Women who are pregnant or lactating

• Diagnosis of IBS-D or IBS-M

• Organic or obstructive disease of the small or large intestine

• Use of laxatives other than the study-supplied rescue medication (Dulcolax®, bisacodyl)

• Use of a prohibited concomitant medication within the time frame prior to screening outlined in the study protocol for that medication

• Unstable medical illness

• Bilirubin > 3X ULN in the absence of a conjugation defect

• Any laboratory value > 3X ULN unless discussed and approved by the study Medical Monitor