An Open-Label Study to Evaluate the Long-Term Safety of Subcutaneous MOA-728 for Treatment of Opioid-Induced Constipation in Subjects With Nonmalignant Pain
Overview
- Phase
- Phase 3
- Intervention
- N-methylnaltrexone bromide (MOA-728)
- Conditions
- Constipation
- Sponsor
- Bausch Health Americas, Inc.
- Enrollment
- 1040
- Locations
- 1
- Primary Endpoint
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
This study is designed to evaluate the long-term safety and tolerability of the subcutaneous (SC) injection form of N-methylnaltrexone bromide (MOA-728) for the treatment of opioid-induced constipation in participants with nonmalignant pain. The study consists of a 2-week screening period, a 48-week open-label treatment period and a 2 week follow-up period. Participants will need to agree to self-administer SC injections, complete daily diaries, and check-in via a daily telephone call during the study.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Men and women 18 years or older.
- •A history of pain of at least 2 months duration before the screening visit due to documented underlying nonmalignant condition.
- •A history of constipation due to opioid use during 1 month before the screening visit.
Exclusion Criteria
- •A diagnosis of significant gastrointestinal (GI) disorder such as bowel obstruction, fecal incontinence or rectal prolapse.
- •A history of active inflammatory bowel disease, irritable bowel syndrome, or megacolon within 6 months before the screening visit.
- •A history of malignancy, other than basal cell or squamous cell skin carcinoma, within 5 years before the screening visit.
- •A history of chronic constipation before initiation of opioid therapy.
Arms & Interventions
MOA-728 12 mg QD
Participants will receive MOA-728 12 milligrams (mg) SC once daily (QD) for 48 weeks. Dosing could be adjusted to an as needed (PRN) basis with a minimum 1 dose per week and maximum 1 dose per day.
Intervention: N-methylnaltrexone bromide (MOA-728)
Outcomes
Primary Outcomes
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time Frame: Baseline up to Week 50
Adverse event (AE) was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Serious adverse events (SAEs) included death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. TEAEs were defined as an AE that emerged during the treatment period. Any TEAEs included both treatment-emergent SAEs and non-serious AEs. A summary of serious and all other non-serious AEs regardless of causality is located in the Reported Adverse Events module.
Secondary Outcomes
- Change From Baseline in Weekly Bowel Movement (BM) Rate Through Follow-up(Baseline, follow-up (14 days [Week 49 to 50]))