Overview

Second Plecanatide Study In Irritable Bowel Syndrome With Constipation (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 ≥ 40 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