Study Evaluating MOA-728 Oral for the Treatment of OIBD in Subjects With Chronic Non-Malignant Pain
- Registration Number
- NCT00605644
- Lead Sponsor
- Bausch Health Americas, Inc.
- Brief Summary
The primary purpose of this study is to evaluate the safety and dose-response relationship of N-methylnaltrexone bromide (MOA-728) by observing spontaneous bowel movements in subjects administered MOA-728 who have chronic pain that is not due to cancer, and who have opioid-induced bowel dysfunction (OIBD).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 128
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo 150 mg MOA-728 MOA-728 300 mg MOA-728 MOA-728 450 mg MOA-728 MOA-728 600 mg MOA-728 MOA-728
- Primary Outcome Measures
Name Time Method Percentage of Participants Witn Spontaneous Bowel Movements Within 3 Hours of Treatment 3 hours
- Secondary Outcome Measures
Name Time Method