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Completed
NCT02387359
The Plecanatide Irritable Bowel Syndrome With Constipation Safety and Efficacy Study (IBS-C)
Conditions: Irritable Bowel Syndrome Characterized by Constipation
Sex: All
Ages: 18 Years – 85 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 1054
Sponsor: Bausch Health Americas, Inc.
Location: Synergy Research Site Athens Alabama
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.
Eligibility 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
Source: ClinicalTrials.gov (NCT02387359). StuddyBuddy aggregates publicly available trial information.