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Lubiprostone in Patients With Multiple Sclerosis Associated Constipation

Primary Purpose

Multiple Sclerosis, Constipation

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Lubiprostone
Placebo
Sponsored by
University of Rochester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple Sclerosis, Constipation, Multiple Sclerosis Associated Constipation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Rochester

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Lubiprostone

Sugar pill

Arm Description

Outcomes

Primary Outcome Measures

Number of Spontaneous Bowel Movements in Patients With Multiple Sclerosis (MS)-Associated Constipation Per Day.
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.
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.

Full Information

First Posted
November 4, 2010
Last Updated
November 6, 2015
Sponsor
University of Rochester
Collaborators
Takeda
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1. Study Identification

Unique Protocol Identification Number
NCT01236534
Brief Title
Lubiprostone in Patients With Multiple Sclerosis Associated Constipation
Official Title
Single-center, Randomized, Double-blind, Placebo-controlled, Parallel-groups Study of Lubiprostone in Patients With Multiple Sclerosis-Associated Constipation
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
Collaborators
Takeda

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Constipation
Keywords
Multiple Sclerosis, Constipation, Multiple Sclerosis Associated Constipation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lubiprostone
Arm Type
Active Comparator
Arm Title
Sugar pill
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Lubiprostone
Other Intervention Name(s)
Amitiza
Intervention Description
24 mcg twice daily for 21 days.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Sugar pill
Intervention Description
matching placebo twice daily for 21 days.
Primary Outcome Measure Information:
Title
Number of Spontaneous Bowel Movements in Patients With Multiple Sclerosis (MS)-Associated Constipation Per Day.
Description
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.
Time Frame
21 days
Secondary Outcome Measure Information:
Title
Number of Participants With Diarrheic Events.
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew D Goodman, MD
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States

12. IPD Sharing Statement

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Lubiprostone in Patients With Multiple Sclerosis Associated Constipation

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