Open-label Extension (OLE) Study of Plecanatide for Chronic Idiopathic Constipation (CIC)
This is a multi-center, open-label, 52-week safety and tolerability study of plecanatide in patients with Chronic Idiopathic Constipation (CIC).
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-Label Extension (OLE), Long-term Safety and Tolerability Study of Plecanatide in Patients With Chronic Idiopathic Constipation (CIC)|
- Safety and Tolerability [ Time Frame: One year ] [ Designated as safety issue: No ]Safety and tolerability will be evaluated based on the occurrence of treatment-emergent adverse events and assessment of: vital signs, clinical laboratory tests, physical examinations and ECGs.
- Patient-Reported Outcomes [ Time Frame: One year ] [ Designated as safety issue: No ]Patients' assessments of their disease symptoms and severity, continued treatment and quality of life will also be evaluated.
|Study Start Date:||August 2013|
|Estimated Study Completion Date:||March 2015|
|Estimated Primary Completion Date:||March 2015 (Final data collection date for primary outcome measure)|
Experimental: Plecanatide 3.0 mg
Plecanatide 3.0 mg, one tablet by mouth daily for 52 weeks
Experimental: Plecanatide 6.0 mg
Plecanatide 6.0 mg, one tablet by mouth daily for 52 weeks
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01919697
Show 160 Study Locations
|Principal Investigator:||Richard A Krause, MD||ClinSearch, LLC|