Single-center, Randomized, Double-blind, Placebo-controlled, Parallel-groups Study of Lubiprostone in Patients With Multiple Sclerosis-Associated Constipation
| City: |
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Rochester |
| State: |
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New York |
| Zip Code: |
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14642 |
| Conditions: |
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Multiple Sclerosis - Constipation |
| Purpose: |
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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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| Study Summary: |
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Multiple Sclerosis (MS) is a disorder of the body's immune system that affects the central
nervous system. Normally, nerve fibers carry electrical impulses through the spinal cord,
providing communication between the brain and the bowel. In people with MS, the covering
around the nerve fibers deteriorates, causing nerve impulses to be slowed or stopped. as a
result, patients with MS may experiences constipation.
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| 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.
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| NCT ID: |
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NCT01236534 |
| Primary Contact: |
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Principal Investigator
Andrew D Goodman, MD
University of Rochester
Cynthia J. Irish, RN, MSCN
Phone: 585-275-6120
Email: cindy_irish@urmc.rochester.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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Rochester, New York 14642
United States
Andrew D. Goodman, MD
Phone: 585-275-7854
Email: andrew_goodman@urmc.rochester.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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June 19, 2013 |
| Modifications to this listing: |
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