NCT01919697

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,370 (actual)
• Sponsor: Bausch Health Americas, Inc. · Industry
• Sex: All
• Age: 18 Years – 81 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Chronic Idiopathic Constipation

Interventions

Type	Name	Description
DRUG	Plecanatide

Timeline

• Start date: 2013-08-01
• Primary completion: 2016-01-01
• Completion: 2016-03-01
• First posted: 2013-08-09
• Last updated: 2019-07-02
• Results posted: 2019-07-02

Locations

220 sites across 2 countries: United States, Canada