Lubiprostone in Patients With Multiple Sclerosis Associated Constipation
|ClinicalTrials.gov Identifier: NCT01236534|
Recruitment Status : Completed
First Posted : November 8, 2010
Results First Posted : December 10, 2015
Last Update Posted : December 10, 2015
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis Constipation||Drug: Lubiprostone Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Single-center, Randomized, Double-blind, Placebo-controlled, Parallel-groups Study of Lubiprostone in Patients With Multiple Sclerosis-Associated Constipation|
|Study Start Date :||November 2010|
|Actual Primary Completion Date :||January 2012|
|Actual Study Completion Date :||April 2012|
|Active Comparator: Lubiprostone||
24 mcg twice daily for 21 days.
Other Name: Amitiza
|Placebo Comparator: Sugar pill||
matching placebo twice daily for 21 days.
Other Name: Sugar pill
- Number of Spontaneous Bowel Movements in Patients With Multiple Sclerosis (MS)-Associated Constipation Per Day. [ Time Frame: 21 days ]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.
- Number of Participants With Diarrheic Events. [ Time Frame: 21 days ]To determine the safety of lubiprostone based on adverse event (AE) type, frequency, and severity. Hypothesis: AE type, frequency, and severity will be comparable in lubiprostone and placebo treated patients.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01236534
|United States, New York|
|University of Rochester|
|Rochester, New York, United States, 14642|
|Principal Investigator:||Andrew D Goodman, MD||University of Rochester|