Study Evaluating Oral MOA-728 For The Treatment Of OIBD In Subjects With Chronic Non-Malignant Pain
Phase 2
Completed
- Conditions
- Constipation
- Interventions
- Other: placeboDrug: N-methylnaltrexone bromide (MOA-728)
- Registration Number
- NCT00547586
- 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 with chronic pain, which is not due to malignant cancer, and who have opioid-induced bowel dysfunction (OIBD).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 122
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 - 150 mg N-methylnaltrexone bromide (MOA-728) - 300 mg N-methylnaltrexone bromide (MOA-728) - 450 mg N-methylnaltrexone bromide (MOA-728) - 600 mg N-methylnaltrexone bromide (MOA-728) -
- Primary Outcome Measures
Name Time Method Percentage of Participants With a Spontaneous Bowel Movement (SBM) Within 1, 2, 3, 4, and 6 Hours of Treatment 6 hours
- Secondary Outcome Measures
Name Time Method