NCT01236534

Lubiprostone in Patients With Multiple Sclerosis Associated Constipation

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: University of Rochester · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Multiple Sclerosis (MS) is a disorder of the body's immune system that affects the central nervous system. Normally, nerve fibers carry electrical impulses through the spinal cord, providing communication between the brain and the bowel. In people with MS, the covering around the nerve fibers deteriorates, causing nerve impulses to be slowed or stopped. as a result, patients with MS may experiences constipation.

Conditions

• Multiple Sclerosis
• Constipation

Interventions

Type	Name	Description
DRUG	Lubiprostone	24 mcg twice daily for 21 days.
DRUG	Placebo	matching placebo twice daily for 21 days.

Timeline

• Start date: 2010-11-01
• Primary completion: 2012-01-01
• Completion: 2012-04-01
• First posted: 2010-11-08
• Last updated: 2015-12-10
• Results posted: 2015-12-10

Locations

1 site across 1 country: United States