At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,394 enrolled
Drug / intervention
Plecanatide +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, 12-Week, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Plecanatide (3.0 and 6.0 mg) in Patients With Chronic Idiopathic Constipation (The CIC3 Study)
In Brief
A Phase 3 clinical trial evaluating Plecanatide, Placebo, and 1 other intervention for Chronic Idiopathic Constipation. Completed, enrolled 1,394 participants across 189 sites in 2 countries.
Detailed Summary
The purpose of this study is to confirm that the investigational medication, plecanatide, is safe and effective in treating chronic idiopathic constipation.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Idiopathic Constipation
CountriesCanada, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartNov 2013
First PostedNov 2013
Primary CompletionApr 2015
Study CompletionJun 2015
TodayJul 2026
First PostedNov 13, 2013
Enrollment StartNov 1, 2013
Primary CompletionApr 1, 2015
Study CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 12.6 years ago
Interventions
Plecanatidedrug
Plecanatide tablets QD for 12 weeks
Placebodrug
Matching placebo tablets QD for 12 weeks
Bisacodyldrug
Rescue medication