Lubiprostone in Patients With Multiple Sclerosis Associated Constipati
Single-center, Randomized, Double-blind, Placebo-controlled, Parallel-groups Study of Lubiprostone in Patients With Multiple Sclerosis-Associated Constipation
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
- Lubiprostone
Chloride channel protein 2 opener
Placebo
- Placebo
Results by group
Number of Spontaneous Bowel Movements in Patients With Multiple Sclerosis (MS)-Associated Constipation Per Day.
21 days
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Lubiprostone | 3.4 spontaneous bowel movements | 0.7 (Standard Deviation) | 11 |
| Sugar Pill | 3.2 spontaneous bowel movements | 0.6 (Standard Deviation) | 10 |
Lubiprostone
Sugar Pill
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Lubiprostone | 11 | 0 (0.0%) | |
| Sugar Pill | 10 | 0 (0.0%) |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Number of Spontaneous Bowel Movements in Patients With Multiple Sclerosis (MS)-Associated Constipation Per Day.
21 days
Bladder, bowel and sexual function
Other measures (1)
Number of Participants With Diarrheic Events.
21 days
Safety
Who could take part
MS (type not specified) · 18 and over
Show the full 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.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
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History
Started
Nov 2010
Main results due
Jan 2012
Finished
Apr 2012
Results posted
Dec 2015