At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 951 enrolled
Drug / intervention
plecanatide +1 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.
Study SP304-20210: A Randomized, 12-Week, Double-Blind, Placebo-Controlled, Repeat-Dose, Oral, Dose-Ranging Study to Assess the Safety and Efficacy of Plecanatide in Patients With Chronic Idiopathic Constipation
In Brief
A Phase 3 clinical trial evaluating plecanatide and Placebo for Chronic Idiopathic Constipation. Completed, enrolled 951 participants across 121 sites.
Detailed Summary
This is a randomized, double-blind, placebo controlled, 12 week repeat oral dose, dose ranging study to determine the efficacy and safety of 3 doses of plecanatide compared to placebo in patients with Chronic Idiopathic Constipation (CIC).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Idiopathic Constipation
CountriesUnited States
CollaboratorsParexel
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedSep 2011
Enrollment StartOct 2011
Primary CompletionDec 2012
TodayJul 2026
First PostedSep 7, 2011
Enrollment StartOct 1, 2011
Primary CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 14.8 years ago
Interventions
plecanatidedrug
Subjects receive experimental study drug for 12 weeks.
Placeboother
Subjects receive experimental study drug for 12 weeks.