Status:
COMPLETED
Open-label Extension (OLE) Study of Plecanatide for Chronic Idiopathic Constipation (CIC)
Lead Sponsor:
Bausch Health Americas, Inc.
Collaborating Sponsors:
Syneos Health
Conditions:
Chronic Idiopathic Constipation
Eligibility:
All Genders
18-81 years
Phase:
PHASE3
Brief 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 duratio...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2016
Estimated Enrollment :
2370 Patients enrolled
Trial Details
Trial ID
NCT01919697
Start Date
August 1 2013
End Date
March 1 2016
Last Update
July 2 2019
Active Locations (220)
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1
Synergy Research Site
Birmingham, Alabama, United States, 35242
2
Synergy Research Site
Dothan, Alabama, United States, 36305
3
Synergy Research Site
Gulf Shores, Alabama, United States, 36542
4
Synergy Research Site
Huntsville, Alabama, United States, 35801