A Phase 4 interventional study of Nalmefene Hydrochloride Injection and Naloxone Hydrochloride Injection in Opioid Overdose, sponsored by Purdue Pharma LP. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-12.
Sponsored by Purdue Pharma LP (part of Knoa Pharma) · Phase 4, Interventional, and Treatment
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.
70 studies on the registry are indexed under Opiate Overdose; 11 are open to participants now.
Browse Opiate Overdose studies →Purdue Pharma LP is the lead sponsor of 58 studies on the registry; none are open to participants now.
First submitted before Purdue Pharma LP became part of Knoa Pharma.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Nalmefene hydrochloride (HCl) injection
Drug: Nalmefene Hydrochloride Injection
Naloxone hydrochloride (HCl) injection
Drug: Naloxone Hydrochloride Injection
for intravenous/intramuscular/subcutaneous (IV/IM/SC) administration
for intravenous/intramuscular/subcutaneous (IV/IM/SC) administration
Also known as: Narcan
Reversal of Respiratory Depression
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.
Time frame: Up to 3 hours
Time to Reversal from administration of opioid antagonist
Time frame: Up to 3 hours
Recurrence of Respiratory Depression
Increased end tidal carbon dioxide value (if measured) above 45 mmHg when previously within the normal range and/or ≥5 breaths per minute decrease in respiratory rate from maximum post-reversal measurement, with a rate of at most 12 breaths per minute.
Time frame: Up to 3 hours
ED Disposition
One of the following will apply: * ED Discharge * Hospital Admission * ICU Admission * Left against medical advice * Transfer to another facility * Death.
Time frame: Up to 3 hours
Drug Dosing
1. Dose administered for each opioid antagonist given to patients during their ED encounter - * Individual dose amount and frequency * Cumulative dose 2. Any pre-hospital naloxone given prior to ED arrival - * Dose amount, route
Time frame: Up to 3 hours
Richmond-Agitation Sedation Scale (RASS) Score
This is a single-item instrument used to quickly assess the degree of patient alertness and agitation in emergency and critical care settings. It is an observational assessment conducted by healthcare providers, and it can be completed in seconds. The scale uses integers from -5 to +4, each with its own clear anchor. A score of 0 means that the patient is alert and calm. Negative integers indicate diminished responsiveness and consciousness, with -1 indicating that a patient will open their eyes or make eye contact for 10 or more seconds when awakened by voice, and -5 meaning that the patient is unarousable by voice or physical stimulation. Positive integers indicate an increased level of arousal or agitation. The positive end of the scale spans from +1 (anxious, apprehensive, but not aggressive) to +4 (combative, violent, danger to staff).
Time frame: Up to 3 hours
Clinical Opioid Withdrawal Scale (COWS) Score
This is an observational assessment performed by a clinician to diagnose and assess the severity of opioid withdrawal symptoms. Eleven different opioid withdrawal symptoms are included in the COWS. The clinician will score the presence and severity of each symptom, with 0 indicating that the symptom is absent and more severe symptoms warranting a higher score. Individual symptom scores are then added to determine the overall severity of the patient's withdrawal. Total scores range from 5 to 48 where 5 - 12 = mild; 13 - 24 = moderate; 25 - 36 moderately severe; and greater than 36 = severe withdrawal.
Time frame: Up to 3 hours
Oxygen saturation level
Pulse oximetry monitoring will be used to assess the patient's oxygen saturation level (SpO2), expressed as a percentage from 0 to 100.
Time frame: Up to 3 hours
Length of time during ED encounter
Defined as the difference between time at Triage to time at ED Disposition
Time frame: Up to 3 hours
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jun 2023; primary completion for May 2024, 11 months later.
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This study is withdrawn, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Nalmefene