Lubiprostone in Patients With Multiple Sclerosis Associated Constipation

• Status: Completed
• Trial end date: 2012-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Rochester
• Collaborator: Takeda
• Treatments: Lubiprostone

Criteria

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.