At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 211 enrolled
Drug / intervention
Lubiprostone +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 Lubiprostone and Placebo for Constipation. Completed, enrolled 211 participants across 10 sites.
Detailed Summary
The purpose of this study is to evaluate the efficacy and safety of oral administration of 24 ug of lubiprostone twice daily (BID) for 4 weeks in participants with chronic idiopathic constipation (CIC) compared with placebo.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsConstipation
CountriesMexico
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedApr 2016
Enrollment StartMay 2016
Primary CompletionApr 2017
Study CompletionJun 2017
TodayJul 2026
First PostedApr 6, 2016
Enrollment StartMay 11, 2016
Primary CompletionApr 28, 2017
Study CompletionJun 5, 2017
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 10.2 years ago
Interventions
Lubiprostonedrug
Lubiprostone capsules
Placebodrug
Lubiprostone placebo-matching capsules