Lubiprostone in Patients With Multiple Sclerosis Associated Constipation
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|