CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 439 enrolled
Drug / intervention
Lubiprostone 24drug
Likely dose
Lubiprostone 24 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/NCT00620061
NCT00620061Phase 3Completed
CompareCT.gov

A Multi-center, Open-labeled Study of the Long-term Safety and Efficacy of Lubiprostone in Patients With Opioid-induced Bowel Dysfunction

Sucampo Pharma Americas, LLC·interventional·Posted Feb 21, 2008·Updated Jan 21, 2020

In Brief

A Phase 3 clinical trial evaluating Lubiprostone 24 for Opioid-Induced Bowel Dysfunction. Completed, enrolled 439 participants across 123 sites in 2 countries.

Detailed Summary

The purpose of this study is to evaluate the long-term safety and efficacy of lubiprostone administration in participants with opioid-induced bowel dysfunction.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOpioid-Induced Bowel Dysfunction
CountriesCanada, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 21, 2008
Enrollment StartDec 1, 2007
Primary CompletionSep 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 18.4 years ago

Interventions

Lubiprostone 24drug

24 mcg capsules for oral administration