Lubiprostone in Patients With Multiple Sclerosis Associated Constipation

Multiple Sclerosis Clinical Trial

Official title:

Single-center, Randomized, Double-blind, Placebo-controlled, Parallel-groups Study of Lubiprostone in Patients With Multiple Sclerosis-Associated Constipation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01236534
• Other study ID #: URMC08-022LUB
• Status: Completed
• Phase: Phase 4
• First received: November 4, 2010
• Last updated: November 6, 2015
• Start date: November 2010
• Est. completion date: April 2012

Study information

• Verified date: November 2015
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: April 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constipation
• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Lubiprostone
24 mcg twice daily for 21 days.
• Placebo
matching placebo twice daily for 21 days.

Locations

Country	Name	City	State
United States	University of Rochester	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	Takeda

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	21 days	No
Secondary	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.	21 days	Yes