A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Oral MOA-728 for the Treatment of Opioid-Induced Bowel Dysfunction in Subjects With Chronic Nonmalignant Pain
Phase 2
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Constipation
Both
Constipation
Trial Information
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Oral MOA-728 for the Treatment of Opioid-Induced Bowel Dysfunction in Subjects With Chronic Nonmalignant Pain
Inclusion Criteria:
- Adult Outpatients with opioid-induced bowel dysfunction and chronic pain, which is
not due to malignant cancer.
- Taking oral, transdermal, intravenous, or subcutaneous opioids.
- Willingness to discontinue all pre-study laxative therapy and use only study
permitted rescue laxatives.
Exclusion Criteria:
- History of chronic constipation before the initiation of opioid therapy.
- Other GI disorders known to affect bowel transit.
- Women who are pregnant, breast feeding, or plan to become pregnant.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Spontaneous Bowel Movements
Outcome Time Frame:
App. 1 month
Safety Issue:
No
Principal Investigator
Jeff Cohn
Investigator Role:
Study Director
Investigator Affiliation:
Salix Pharmaceuticals
Authority:
United States: Food and Drug Administration
Study ID:
3200A3-2202
NCT ID:
NCT00605644
Start Date:
January 2008
Completion Date:
May 2008
Related Keywords:
- Constipation
- Constipation
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