Phase 4 Completed N=21 Randomized Double-blind Treatment

Lubiprostone in Patients With Multiple Sclerosis Associated Constipation

Multiple Sclerosis · chronic constipation

Source: ClinicalTrials.gov NCT01236534 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2015

Primary outcomePrimary: Number of Spontaneous Bowel Movements in Patients With Multiple Sclerosis (MS)-Associated Constipation Per Day. — 3.4; 3.2 spontaneous bowel movements

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Spontaneous Bowel Movements in Patients With Multiple Sclerosis (MS)-Associated Constipation Per Day.	3.4; 3.2	—
SECONDARY Number of Participants With Diarrheic Events.	8; 2	—

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01236534). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.