Study Evaluating Subcutaneous MOA-728 for the Treatment of Opioid-Induced Constipation (OIC) in Subjects With Chronic Non-Malignant Pain
CompletedPhase 3NCT00529087
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
The primary purpose of the protocol is to evaluate the safety, efficacy, and tolerability of subcutaneous MOA-728 versus placebo in subjects with chronic non-malignant pain who have Opioid-Induced Constipation (OIC).
Study details
- Official title
- A Mulitcenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Subcutaneous MOA-728 for the Treatment of Opioid-Induced Constipation in Subjects With Chronic Non-Malignant Pain
- Conditions
- Interventions
- Drug: N-methylnaltrexone bromide (MOA-728)
- Other: placebo
- Sponsor
- Bausch Health Americas, Inc.
- Collaborators
- Progenics Pharmaceuticals, Inc.
- Start date
- 2007-08
- Primary completion
- 2008-12
- Sex
- All
- Age range
- from 18 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United States
- Total sites listed
- 78
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Adult outpatients with opioid-induced constipation and chronic non-malignant pain. * 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.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00529087