Phase 4
N=21
Lubiprostone in Patients With Multiple Sclerosis Associated Constipation
Multiple Sclerosis · Constipation
Bottom Line
View on ClinicalTrials.gov: NCT01236534 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Dec 2015
Primary outcome: Primary: Number of Spontaneous Bowel Movements in Patients With Multiple Sclerosis (MS)-Associated Constipation Per Day. — 3.4; 3.2 spontaneous bowel movements
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Lubiprostone (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Rochester
- Primary completion
- Jan 2012
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 | — |
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.
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.
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.