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Lubiprostone in Patients With Multiple Sclerosis Associated Constipation

This study is currently recruiting participants.
Verified August 2011 by University of Rochester
Sponsor:
Collaborator:
Takeda Global Research & Development Center, Inc.
Information provided by:
University of Rochester
ClinicalTrials.gov Identifier:
NCT01236534
First received: November 4, 2010
Last updated: August 2, 2011
Last verified: August 2011
History of Changes
  Purpose

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
Constipation
 Drug: Lubiprostone
Drug: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

U.S. FDA Resources

Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • To determine the effect of lubiprostone 24 mcg twice daily on spontaneous bowel movements in patients with MS-associated constipation [ Time Frame: 21 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: November 2010
Estimated Study Completion Date: November 2011
Estimated Primary Completion Date: November 2011 (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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01236534

Contacts
Contact: Cynthia J. Irish, RN, MSCN 585-275-6120 cindy_irish@urmc.rochester.edu

Locations
United States, New York
University of Rochester Recruiting
Rochester, New York, United States, 14642
Contact: Andrew D. Goodman, MD     585-275-7854     andrew_goodman@urmc.rochester.edu    
Principal Investigator: Andrew D. Goodman, MD            
Sponsors and Collaborators
University of Rochester
Takeda Global Research & Development Center, Inc.
Investigators
Principal Investigator: Andrew D Goodman, MD University of Rochester
  More Information

No publications provided

Responsible Party: Andrew D. Goodman, MD, University of Rochester Medical Center
ClinicalTrials.gov Identifier: NCT01236534     History of Changes
Other Study ID Numbers: URMC08-022LUB
Study First Received: November 4, 2010
Last Updated: August 2, 2011
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Constipation
Multiple Sclerosis
Sclerosis
Signs and Symptoms, Digestive
Signs and Symptoms
Demyelinating Autoimmune Diseases, CNS
 Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 22, 2013