Open-label Extension (OLE) Study of Plecanatide for Chronic Idiopathic Constipation (CIC)
|ClinicalTrials.gov Identifier: NCT01919697|
Recruitment Status : Completed
First Posted : August 9, 2013
Last Update Posted : August 15, 2016
|Condition or disease||Intervention/treatment||Phase|
|Chronic Idiopathic Constipation||Drug: Plecanatide||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2370 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label Extension (OLE), Long-term Safety and Tolerability Study of Plecanatide in Patients With Chronic Idiopathic Constipation (CIC)|
|Study Start Date :||August 2013|
|Actual Primary Completion Date :||January 2016|
|Actual Study Completion Date :||March 2016|
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
- Safety and Tolerability [ Time Frame: One year ]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 ]Patients' assessments of their disease symptoms and severity, continued treatment and quality of life will also be evaluated.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01919697
Show 221 Study Locations
|Principal Investigator:||Richard A Krause, MD||ClinSearch, LLC|