Lubiprostone in Patients With Multiple Sclerosis Associated Constipation

NCT01236534 | Completed Phase 4 Results

• 1 other identifier: URMC08-022LUB
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis; Constipation

Keywords

Multiple Sclerosis; Constipation; Multiple Sclerosis Associated Constipation

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Number of Participants With Diarrheic Events.

  21 days

Study Arms (2)

Lubiprostone

ACTIVE COMPARATOR

Drug: Lubiprostone

Sugar pill

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Lubiprostone DRUG

24 mcg twice daily for 21 days.

Also known as: Amitiza

Lubiprostone

Placebo DRUG

matching placebo twice daily for 21 days.

Also known as: Sugar pill

Sugar pill

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Rochester: lead
• Takeda: collaborator

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis; Constipation

Interventions

Lubiprostone; Sugars

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Alprostadil; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Carbohydrates

Results Point of Contact

• Title: Andrew Goodman, MD
• Organization: University of Rochester

andrew_goodman@urmc.rochester.edu

585-275-7854

Study Officials

• Andrew D Goodman, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 4, 2010
• First Posted: November 8, 2010
• Study Start: November 1, 2010
• Primary Completion: January 1, 2012
• Study Completion: April 1, 2012
• Last Updated: December 10, 2015
• Results First Posted: December 10, 2015

Record last verified: 2015-11

Locations

US (1)