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Lubiprostone in Patients With Multiple Sclerosis Associated Constipation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01236534
Recruitment Status : Completed
First Posted : November 8, 2010
Results First Posted : December 10, 2015
Last Update Posted : December 10, 2015
Information provided by (Responsible Party):
Andrew Goodman, University of Rochester

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 by the FDA for the treatment of two common types of constipation in adults, chronic idiopathic constipation and irritable bowel syndrome.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Constipation Drug: Lubiprostone Drug: Placebo Phase 4

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 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : November 2010
Actual Primary Completion Date : January 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Lubiprostone Drug: Lubiprostone
24 mcg twice daily for 21 days.
Other Name: Amitiza

Placebo Comparator: Sugar pill Drug: Placebo
matching placebo twice daily for 21 days.
Other Name: Sugar pill

Primary Outcome Measures :
  1. Number of Spontaneous Bowel Movements in Patients With Multiple Sclerosis (MS)-Associated Constipation Per Day. [ Time Frame: 21 days ]
    Number of of lubiprostone 24 mcg twice daily on spontaneous bowel movements (SBM) in patients with multiple sclerosis (MS)-associated constipation per day. Hypothesis: Lubiprostone-treated patients will have more SBM's than placebo-treated patients.

Secondary Outcome Measures :
  1. Number of Participants With Diarrheic Events. [ Time Frame: 21 days ]
    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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01236534

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United States, New York
University of Rochester
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
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Principal Investigator: Andrew D Goodman, MD University of Rochester
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Responsible Party: Andrew Goodman, MD, University of Rochester Identifier: NCT01236534    
Other Study ID Numbers: URMC08-022LUB
First Posted: November 8, 2010    Key Record Dates
Results First Posted: December 10, 2015
Last Update Posted: December 10, 2015
Last Verified: November 2015
Keywords provided by Andrew Goodman, University of Rochester:
Multiple Sclerosis
Multiple Sclerosis Associated Constipation
Additional relevant MeSH terms:
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Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Signs and Symptoms, Digestive
Chloride Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action