CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 437 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/NCT00597428
NCT00597428Phase 3Completed
CompareCT.gov

A Multi-center, Randomized, Double-Blinded Study of the Efficacy and Safety of Lubiprostone in Patients With Opioid-induced Bowel Dysfunction (OBD)

Sucampo Pharma Americas, LLC·interventional·Posted Jan 18, 2008·Updated Dec 10, 2019

In Brief

A Phase 3 clinical trial evaluating Lubiprostone and Placebo for Opioid-Induced Bowel Dysfunction. Completed, enrolled 437 participants across 114 sites in 2 countries.

Detailed Summary

The primary purpose of this study is to evaluate the efficacy and safety of lubiprostone administration in patients with opioid-induced bowel dysfunction (OBD).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOpioid-Induced Bowel Dysfunction
CountriesCanada, United States
CollaboratorsSucampo Pharmaceuticals, Inc.

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 18, 2008
Enrollment StartAug 1, 2007
Primary CompletionMar 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 18.5 years ago

Interventions

Lubiprostonedrug

24 mcg capsules twice daily (BID)

Placebodrug

0 mcg capsules twice daily (BID)