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

• Status: Completed
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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

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

Details

• Lead Sponsor: Bausch Health Americas, Inc.; Synergy Pharmaceuticals Inc.
• Collaborators: INC Research; Syneos Health
• Treatments: Plecanatide

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.