At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 156 enrolled
Drug / intervention
Placebo +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.
A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lubiprostone for the Treatment of Chronic Idiopathic Constipation
In Brief
A Phase 3 clinical trial evaluating Placebo and Lubiprostone for Chronic Idiopathic Constipation. Completed, enrolled 156 participants across 5 sites.
Detailed Summary
The purpose of this study was to evaluate the efficacy and safety of oral administration of lubiprostone 24 μg twice daily (BID) for 4 weeks in participants with chronic idiopathic constipation (CIC) compared with placebo.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Idiopathic Constipation
CountriesSouth Korea
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 2016
Enrollment StartApr 2016
Primary CompletionJan 2017
Study CompletionFeb 2017
TodayJul 2026
First PostedMar 1, 2016
Enrollment StartApr 14, 2016
Primary CompletionJan 20, 2017
Study CompletionFeb 24, 2017
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 10.3 years ago
Interventions
Placebodrug
Lubiprostone placebo-matching capsules
Lubiprostonedrug
Lubiprostone capsules