Phase 2
N=128
Study Evaluating MOA-728 Oral for the Treatment of OIBD in Subjects With Chronic Non-Malignant Pain
Constipation
Bottom Line
View on ClinicalTrials.gov: NCT00605644 ↗Enrolled (actual)
128
Serious AEs
2.3%
Results posted
Aug 2020
Primary outcome: Primary: Percentage of Participants Witn Spontaneous Bowel Movements Within 3 Hours of Treatment — 2; 3; 2; 5 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- MOA-728 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bausch Health Americas, Inc.
- Primary completion
- May 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Witn Spontaneous Bowel Movements Within 3 Hours of Treatment |
2; 3; 2; 5; 6 | — |
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).
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00605644). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.