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Lubiprostone in Patients With Multiple Sclerosis Associated Constipation

NCT ID: NCT01236534

Last Updated: 2015-12-10

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2012-04-30

Brief Summary

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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

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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.

Conditions

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Multiple Sclerosis Constipation

Keywords

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Multiple Sclerosis Constipation Multiple Sclerosis Associated Constipation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Lubiprostone

Group Type ACTIVE_COMPARATOR

Lubiprostone

Intervention Type DRUG

24 mcg twice daily for 21 days.

Sugar pill

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

matching placebo twice daily for 21 days.

Interventions

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Lubiprostone

24 mcg twice daily for 21 days.

Intervention Type DRUG

Placebo

matching placebo twice daily for 21 days.

Intervention Type DRUG

Other Intervention Names

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Amitiza Sugar pill

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Takeda

INDUSTRY

Sponsor Role collaborator

University of Rochester

OTHER

Sponsor Role lead

Responsible Party

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Andrew Goodman

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrew D Goodman, MD

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

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University of Rochester

Rochester, New York, United States

Site Status

Countries

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United States

Other Identifiers

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URMC08-022LUB

Identifier Type: -

Identifier Source: org_study_id