Multiple Sclerosis | Lubiprostone in Patients With Multiple Sclerosis Associated Constipation
Multiple Sclerosis research study
What is the primary objective of this study?
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.
Who is eligible to participate?
Inclusion Criteria: - 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 Criteria: - 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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Lubiprostone24 mcg twice daily for 21 days.
Drug:Placebomatching placebo twice daily for 21 days.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Start Date: November 2010
Completed Date: April 2012
Phase: Phase 4
Primary Outcome: Number of Spontaneous Bowel Movements in Patients With Multiple Sclerosis (MS)-Associated Constipation Per Day.
Secondary Outcome: Number of Participants With Diarrheic Events.
Study sponsors, principal investigator, and references
Principal Investigator: Andrew D Goodman, MD
Lead Sponsor: University of Rochester