Lubiprostone in Patients With Multiple Sclerosis Associated Constipation

NCT01236534 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2015-12-10

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

DRUG

Lubiprostone

24 mcg twice daily for 21 days.

DRUG

Placebo

matching placebo twice daily for 21 days.

Sponsors & Collaborators

  • Takeda

    collaborator INDUSTRY
  • University of Rochester

    lead OTHER

Principal Investigators

  • Andrew D Goodman, MD · University of Rochester

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2012-01-31
Completion
2012-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01236534 on ClinicalTrials.gov