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, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
The effect of the interventional treatment will be measured by bowel movements.
Outcome Time Frame:
1 month
Safety Issue:
No
Principal Investigator
Medical Monitor
Investigator Role:
Study Director
Investigator Affiliation:
Wyeth is now a wholly owned subsidiary of Pfizer
Authority:
United States: Food and Drug Administration
Study ID:
3200A3-2201
NCT ID:
NCT00547586
Start Date:
October 2007
Completion Date:
February 2008
Related Keywords:
- Constipation
- Constipation
Name | Location |
|---|---|
| Hinsdale, Illinois 60521 | |
| Birmingham, Alabama 35294 | |
| Phoenix, Arizona 85012 | |
| Fountain Valley, California 92708 | |
| Miami, Florida 33176 | |
| Cleveland, Ohio 44195 | |
| Nashville, Tennessee 37203-1632 | |
| Austin, Texas 78705 | |
| Flint, Michigan 48532 | |
| McLean, Virginia 22101 | |
| Albuquerque, New Mexico 87131-5636 | |
| Metairie, Louisiana 70006 | |
| Baltimore, Maryland 21287 | |
| Boston, Massachusetts | |
| Charlotte, North Carolina | |
| Eugene, Oregon | |
| Indianapolis, Indiana | |
| Las Vegas, Nevada 89109 | |
| Jackson, Mississippi |
