Status:
COMPLETED
Study Evaluating Oral MOA-728 for the Treatment of Opioid-Induced Bowel Dysfunction (OIBD) in Subjects With Chronic Non-Malignant Pain
Lead Sponsor:
Bausch Health Americas, Inc.
Conditions:
Constipation
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The primary purpose of the protocol is to evaluate the safety, efficacy, and tolerability of MOA-728 in subjects with Opioid-Induced Bowel Dysfunction (OIBD) with associated chronic non-malignant pain...
Eligibility Criteria
Inclusion
- Adult outpatients with opioid-induced bowel dysfunction and chronic non-malignant pain.
- Taking oral, transdermal, intravenous, or subcutaneous opioids.
- Willingness to discontinue all pre-study laxative therapy and utilize only study permitted rescue laxatives.
Exclusion
- 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.
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
End Date :
March 1 2007
Estimated Enrollment :
420 Patients enrolled
Trial Details
Trial ID
NCT00366431
Start Date
August 1 2006
End Date
March 1 2007
Last Update
November 25 2019
Active Locations (67)
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1
Birmingham, Alabama, United States, 35215
2
Birmingham, Alabama, United States, 35244
3
Mobile, Alabama, United States, 36608
4
Phoenix, Arizona, United States, 85029