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

Chronic Idiopathic Constipation Clinical Trial

Official title:
An Open-Label Extension (OLE), Long-term Safety and Tolerability Study of Plecanatide in Patients With Chronic Idiopathic Constipation (CIC)

Clinical Trial Summary

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

Clinical Trial Description

This is an open-label extension study of plecanatide in the treatment of patients with CIC who previously completed Synergy Protocols SP304-20210 and SP304203-00 (The CIC3 Study).

The planned duration of each patient's study participation is up to 411 days, including up to 33 days of screening, 8 study visits over 52 weeks of treatment and a follow-up visit 2 weeks after the last dose of study drug. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01919697
Study type Interventional
Source Bausch Health Americas, Inc.
Contact
Status Completed
Phase Phase 3
Start date August 2013
Completion date March 2016
View Details
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