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

Completed · Phase 3 · Has a placebo group

Conditions studied: Irritable Bowel Syndrome Characterized by Constipation

In brief

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.

Key facts

Study ID

NCT02387359

Run by

Bausch Health Americas, Inc.

People needed

1054

Starts

2014-12-01

Expected to finish

2017-02-01

Last updated by the study team

2019-06-14

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Synergy Research Site — Birmingham, Alabama, United States
• Synergy Research Site — Dothan, Alabama, United States
• Synergy Research Site — Foley, Alabama, United States
• Synergy Research Site — Huntsville, Alabama, United States
• Synergy Research Site — Montgomery, Alabama, United States
• Synergy Research Site — Chandler, Arizona, United States
• Synergy Research Site — Glendale, Arizona, United States
• Synergy Research Site — Phoenix, Arizona, United States
• Synergy Research Site — Tucson, Arizona, United States
• Synergy Research Site — Tucson, Arizona, United States
• Synergy Research Site — Conway, Arkansas, United States
• Synergy Research Site — Little Rock, Arkansas, United States
• Synergy Research Site — Little Rock, Arkansas, United States
• Synergy Research Site — Anaheim, California, United States
• Synergy Research Site — Artesia, California, United States
• Synergy Research Site — Chula Vista, California, United States
• Synergy Research Site — Corona, California, United States
• Synergy Research Site — Encino, California, United States
• Synergy Research Site — Fountain Valley, California, United States
• Synergy Research Site — Fresno, California, United States
• Synergy Research Site — Garden Grove, California, United States
• Synergy Research Site — La Mesa, California, United States
• Synergy Research Site — La Mirada, California, United States
• Synergy Research Site — Laguna Hills, California, United States
• Synergy Research Site — Athens, Alabama, United States

Full record on ClinicalTrials.gov

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