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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
21
24 mcg twice daily for 21 days.
matching placebo twice daily for 21 days.
University of Rochester
Rochester, New York, United States
Number of Spontaneous Bowel Movements in Patients With Multiple Sclerosis (MS)-Associated Constipation Per Day.
Number of of lubiprostone 24 mcg twice daily on spontaneous bowel movements (SBM) in patients with multiple sclerosis (MS)-associated constipation per day. Hypothesis: Lubiprostone-treated patients will have more SBM's than placebo-treated patients.
Time frame: 21 days
Number of Participants With Diarrheic Events.
To determine the safety of lubiprostone based on adverse event (AE) type, frequency, and severity. Hypothesis: AE type, frequency, and severity will be comparable in lubiprostone and placebo treated patients.
Time frame: 21 days
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