Lubiprostone in Patients With Multiple Sclerosis Associated Constipation

Completed · Phase 4 · Has a placebo group

Conditions studied: Multiple Sclerosis, Constipation

In brief

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.

Key facts

Study ID

NCT01236534

Run by

University of Rochester

People needed

21

Starts

2010-11-01

Expected to finish

2012-04-01

Last updated by the study team

2015-12-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Rochester — Rochester, New York, United States

Full record on ClinicalTrials.gov

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