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Lubiprostone in Patients With Multiple Sclerosis Associated Constipation

This study has been completed.
Information provided by (Responsible Party):
Andrew Goodman, University of Rochester Identifier:
First received: November 4, 2010
Last updated: November 6, 2015
Last verified: November 2015
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 Intervention Phase
Multiple Sclerosis
Drug: Lubiprostone
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:

Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • 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:
  • 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.

Enrollment: 21
Study Start Date: November 2010
Study Completion Date: April 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT01236534

United States, New York
University of Rochester
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Principal Investigator: Andrew D Goodman, MD University of Rochester
  More Information

Responsible Party: Andrew Goodman, MD, University of Rochester Identifier: NCT01236534     History of Changes
Other Study ID Numbers: URMC08-022LUB
Study First Received: November 4, 2010
Results First Received: January 31, 2013
Last Updated: November 6, 2015

Keywords provided by University of Rochester:
Multiple Sclerosis
Multiple Sclerosis Associated Constipation

Additional relevant MeSH terms:
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
Signs and Symptoms
Chloride Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action processed this record on April 27, 2017