Open-label Extension (OLE) Study of Plecanatide for Chronic Idiopathic Constipation (CIC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|