Lubiprostone in Patients With Multiple Sclerosis Associated Constipation

This study has been completed.
Sponsor:
Collaborator:
Takeda
Information provided by (Responsible Party):
Andrew Goodman, University of Rochester
ClinicalTrials.gov Identifier:
NCT01236534
First received: November 4, 2010
Last updated: November 6, 2015
Last verified: November 2015
  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:


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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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.
  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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01236534

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

Responsible Party: Andrew Goodman, MD, University of Rochester
ClinicalTrials.gov 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
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
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes
Signs and Symptoms
Signs and Symptoms, Digestive
Lubiprostone
Chloride Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 26, 2016