Open-label Extension (OLE) Study of Plecanatide for Chronic Idiopathic Constipation (CIC)

Completed · Phase 3

Conditions studied: Chronic Idiopathic Constipation

In brief

This is a multi-center, open-label, 52-week safety and tolerability study of plecanatide in patients with Chronic Idiopathic Constipation (CIC).

Key facts

Study ID

NCT01919697

Run by

Bausch Health Americas, Inc.

People needed

2370

Starts

2013-08-01

Expected to finish

2016-03-01

Last updated by the study team

2019-07-02

Who can join

Age: 18 and older, up to 81. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient completed a previous double-blind plecanatide study and was compliant with the study requirements.
• Patient is in good health without unstable acute illness or exacerbation of an unstable chronic illness or chronic disease that may affect study assessments, particularly if there has been a significant change to health status since the previous plecanatide study.

You may not qualify if…

• Patient has had major surgery including laparoscopic procedures requiring general anesthesia within 60 days of Day 1.
• Patient has a medical history of hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection.
• Patient has taken a protocol-prohibited drug without the appropriate washout period.

Where it is running

• Synergy Research Site — Dothan, Alabama, United States
• Synergy Research Site — Gulf Shores, Alabama, United States
• Synergy Research Site — Huntsville, Alabama, United States
• Synergy Research Site — Chandler, Arizona, United States
• Synergy Research Site — Phoenix, Arizona, United States
• Synergy Research Site — Tempe, Arizona, United States
• Synergy Research Site — Tucson, Arizona, United States
• Synergy Research Site — Tucson, Arizona, United States
• Synergy Research Site — Tucson, Arizona, United States
• Synergy Research Site — Little Rock, Arkansas, United States
• Synergy Research Site — North Little Rock, Arkansas, United States
• Synergy Research Site — Anaheim, California, United States
• Synergy Research Site — Anaheim, California, United States
• Synergy Research Site — Artesia, California, United States
• Synergy Research Site — Carlsbad, California, United States
• Synergy Research Site — Cerritos, California, United States
• Synergy Research Site — Chula Vista, California, United States
• Synergy Research Site — Corona, California, United States
• Synergy Research Site — Encinitas, California, United States
• Synergy Research Site — Fountain Valley, California, United States
• Synergy Research Site — Fresno, California, United States
• Synergy Research Site — Hawaiian Gardens, California, United States
• Synergy Research Site — La Mirada, California, United States
• Synergy Research Site — Laguna Hills, California, United States
• Synergy Research Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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