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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01236534 |
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Date of registration:
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04/11/2010 |
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Primary sponsor: |
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Public title:
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Lubiprostone in Patients With Multiple Sclerosis Associated Constipation
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Scientific title:
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Single-center, Randomized, Double-blind, Placebo-controlled, Parallel-groups Study of Lubiprostone in Patients With Multiple Sclerosis-Associated Constipation |
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Date of first enrolment:
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November 2010 |
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Target sample size:
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40 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01236534 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Andrew D. Goodman, MD |
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Address:
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Telephone:
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585-275-7854 |
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Email:
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andrew_goodman@urmc.rochester.edu |
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Affiliation:
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Name:
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Cynthia J. Irish, RN, MSCN |
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Address:
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Telephone:
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585-275-6120 |
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Email:
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cindy_irish@urmc.rochester.edu |
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Affiliation:
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Name:
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Andrew D Goodman, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Rochester |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Constipation
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Multiple Sclerosis
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Intervention(s)
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Drug: Lubiprostone
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Drug: Placebo
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Primary Outcome(s)
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To determine the effect of lubiprostone 24 mcg twice daily on spontaneous bowel movements in patients with MS-associated constipation
[Time Frame: 21 days]
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Secondary Outcome(s)
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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.
[Time Frame: 21 days]
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Secondary ID(s)
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URMC08-022LUB
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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