Lubiprostone in Patients With Multiple Sclerosis Associated Constipation
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 Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Single-center, Randomized, Double-blind, Placebo-controlled, Parallel-groups Study of Lubiprostone in Patients With Multiple Sclerosis-Associated Constipation|
- To determine the effect of lubiprostone 24 mcg twice daily on spontaneous bowel movements in patients with MS-associated constipation [ Time Frame: 21 days ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2010|
|Estimated Study Completion Date:||November 2011|
|Estimated Primary Completion Date:||November 2011 (Final data collection date for primary outcome measure)|
|Active Comparator: Lubiprostone||
24 mcg twice daily for 21 days.
Other Name: Amitiza
|Placebo Comparator: Sugar pill||
matching placebo twice daily for 21 days.
Other Name: Sugar pill
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.
|Contact: Cynthia J. Irish, RN, MSCNemail@example.com|
|United States, New York|
|University of Rochester||Recruiting|
|Rochester, New York, United States, 14642|
|Contact: Andrew D. Goodman, MD 585-275-7854 firstname.lastname@example.org|
|Principal Investigator: Andrew D. Goodman, MD|
|Principal Investigator:||Andrew D Goodman, MD||University of Rochester|