Phase 3
N=1,040
Study Evaluating Long-Term Safety of MOA-728 in Participants With Opioid-Induced Constipation
Constipation
Bottom Line
View on ClinicalTrials.gov: NCT00804141 ↗Enrolled (actual)
1,040
Serious AEs
10.1%
Results posted
Oct 2019
Primary outcome: Primary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) — 817; 104 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- N-methylnaltrexone bromide (MOA-728) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bausch Health Americas, Inc.
- Primary completion
- Sep 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) |
817; 104 | — |
| SECONDARY Change From Baseline in Weekly Bowel Movement (BM) Rate Through Follow-up |
3.9; 0.5 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT00804141). 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.