Last reviewed · How we verify
Clinical Outcomes From Injectable Nalmefene in the Emergency Department (COINED)
The purpose of this study is to assess the effectiveness of nalmefene relative to naloxone for the reversal of opioid intoxication in emergency department (ED) settings.
Details
| Lead sponsor | Purdue Pharma LP |
|---|---|
| Phase | Phase 4 |
| Status | WITHDRAWN |
| Start date | 2023-06 |
| Completion | 2024-05 |
Conditions
- Opioid Overdose
Interventions
- Nalmefene Hydrochloride Injection
- Naloxone Hydrochloride Injection
Primary outcomes
- Reversal of Respiratory Depression — Up to 3 hours
Normalization of the end tidal carbon dioxide value (if measured) to between 35 and 45 mmHg and/or ≥5 breaths per minute increase in respiratory rate from baseline (pre-dose) measurement, with rate of at least 12 breaths per minute.