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NCT01236534 · ClinicalTrials.gov registry record · Phase 4
Lubiprostone in Patients With Multiple Sclerosis Associated Constipation
A Phase 4 study of Multiple Sclerosis and Constipation, sponsored by University of Rochester.
- Completed
- Registry status
- Phase 4
- Development phase
- 21
- Enrollment target
- 1
- Study location
NCT01236534: Completed Phase 4 study of Multiple Sclerosis and Constipation, sponsored by University of Rochester.
NCT01236534 is a Phase 4 study of Multiple Sclerosis and Constipation that has completed, run by University of Rochester. The registered enrollment target is 21 participants, below the 585-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01236534, a Phase 4 study of Multiple Sclerosis and Constipation, has completed, sponsored by University of Rochester.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 21 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Lubiprostone
Study Locations (1)
New York
- University of Rochester - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2010-11 |
| Est. Completion | 2012-04 |
| Phase | Phase 4 |
What the finished NCT01236534 record still lists
NCT01236534 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 585-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (96% lower).
The record links to 2 conditions, with Multiple Sclerosis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01236534 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT01236534 about?
NCT01236534 is a clinical study titled "Lubiprostone in Patients With Multiple Sclerosis Associated Constipation". 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 const...
What is the current status of trial NCT01236534?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 21 participants. The study started on 2010-11. Estimated completion is 2012-04.
What conditions does trial NCT01236534 study?
This clinical trial studies the following conditions: Multiple Sclerosis, Constipation.
What interventions are being tested in trial NCT01236534?
The interventions under investigation include: Placebo (DRUG), Lubiprostone (DRUG).
Who is sponsoring clinical trial NCT01236534?
This trial is sponsored by University of Rochester, which has 636 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01236534 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Multiple Sclerosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01236534's enrollment target sits among peer trials
21 259th of 315 higher than 55 of 315 other Multiple Sclerosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Multiple Sclerosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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