Conditions: Chronic Idiopathic Constipation
Keywords: Plecantaide Chronic Idiopathic Constipation Chronic Idiopathic Constipation Synergy CIC CIC study CIC OLE CIC OLE study OLE OLE CIC OLE CIC3 Open label Open label study Long term Long term study Extension Extension study
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 2370
Healthy volunteers: no

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 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.

Arms:
arm 1: Plecanatide 3.0 mg, one tablet by mouth daily for 52 weeks arm 2: Plecanatide 6.0 mg, one tablet by mouth daily for 52 weeks

Interventions: intervention 1: Plecanatide
Intervention descriptions: intervention 1: None

Protocol document: