CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 21 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/NCT01236534
NCT01236534Phase 4Completed

Single-center, Randomized, Double-blind, Placebo-controlled, Parallel-groups Study of Lubiprostone in Patients With Multiple Sclerosis-Associated Constipation

University of Rochester·interventional·Posted Nov 8, 2010·Updated Dec 10, 2015

In Brief

A Phase 4 clinical trial evaluating Lubiprostone and Placebo for Multiple Sclerosis and Constipation. Completed, enrolled 21 participants across 1 site.

Detailed Summary

The purpose of the study is to assess how safe and effective the drug Lubiprostone is in people with Multiple Sclerosis (MS)and moderate to severe MS-associated constipation. Lubiprostone is approved by the FDA for the treatment of two common types of constipation in adults, chronic idiopathic constipation and irritable bowel syndrome.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsTakeda

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedNov 8, 2010
Enrollment StartNov 1, 2010
Primary CompletionJan 1, 2012
Study CompletionApr 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 15.7 years ago

Interventions

Lubiprostonedrug

24 mcg twice daily for 21 days.

Placebodrug

matching placebo twice daily for 21 days.