Status:
COMPLETED
Lubiprostone in Patients With Multiple Sclerosis Associated Constipation
Lead Sponsor:
University of Rochester
Collaborating Sponsors:
Takeda
Conditions:
Multiple Sclerosis
Constipation
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 ...
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 communica...
Eligibility Criteria
Inclusion
- Multiple Sclerosis
- Chronic Constipation defined as \< 3 spontaneous bowel movements per week by history and confirmed by diary during the 14 day washout period.
- Women of child-bearing potential must agree to use adequate birth control.
Exclusion
- history of other clinically significant medical or psychiatric disorders or suicidal ideation.
- Subjects who have a suspicion of a mechanical bowel obstruction by clinical evaluation prior to dosing that include nausea, vomiting, abdominal pain or distention.
- Subjects with a positive urine pregnancy test prior to dosing.
- Medication changes within one month prior to visit one.
- Corticosteroid use within 2 months prior to visit one.
- Age\<18.
- Known intolerance to lubiprostone.
- Inability to perform any required study procedures.
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT01236534
Start Date
November 1 2010
End Date
April 1 2012
Last Update
December 10 2015
Active Locations (1)
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1
University of Rochester
Rochester, New York, United States, 14642