CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 439 enrolled
Drug / intervention
Lubiprostone +1 moredrug
Likely dose
Lubiprostone 24 mcgfrom 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.

Search/NCT01298219
NCT01298219Phase 3Completed
CompareCT.gov

A Multicenter, Randomized, Placebo-controlled, Double-blinded Study of the Efficacy and Safety of Lubiprostone in Subjects With Opioid-induced Bowel Dysfunction

Sucampo Pharma Americas, LLC·interventional·Posted Feb 17, 2011·Updated Feb 11, 2020

In Brief

A Phase 3 clinical trial evaluating Lubiprostone and Placebo for Opioid-induced Bowel Dysfunction. Completed, enrolled 439 participants across 142 sites in 7 countries.

Detailed Summary

The primary purpose of the study is to evaluate the efficacy and safety of lubiprostone administration in subjects with Opioid-induced Bowel Dysfunction.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOpioid-induced Bowel Dysfunction
CountriesBelgium, Czechia, Germany, Poland, Sweden, United Kingdom, United States
CollaboratorsSucampo Pharmaceuticals, Inc.

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 17, 2011
Enrollment StartDec 1, 2010
Primary CompletionNov 1, 2011
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 15.4 years ago

Interventions

Lubiprostonedrug

24 mcg administered orally twice daily (BID)

Placebodrug

Matching placebo, 0 mcg administered orally twice daily (BID)