Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE4
INTERVENTIONAL
2023-06-30
2024-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Nalmefene
Nalmefene hydrochloride (HCl) injection
Nalmefene Hydrochloride Injection
for intravenous/intramuscular/subcutaneous (IV/IM/SC) administration
Naloxone
Naloxone hydrochloride (HCl) injection
Naloxone Hydrochloride Injection
for intravenous/intramuscular/subcutaneous (IV/IM/SC) administration
Interventions
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Nalmefene Hydrochloride Injection
for intravenous/intramuscular/subcutaneous (IV/IM/SC) administration
Naloxone Hydrochloride Injection
for intravenous/intramuscular/subcutaneous (IV/IM/SC) administration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Experiencing clinically significant respiratory depression based on appropriate medical judgement.
3. Patient airway is open and unobstructed at the time of enrollment. (Utilization of oral pharyngeal or nasal pharyngeal airway is allowed.)
4. Pre-hospital naloxone administration is allowed.
Exclusion Criteria
2. Patient has one or more additional documented acute medical, traumatic, toxicologic, or psychiatric conditions that would extend length of treatment or adversely alter the clinical outcome.
3. Cardiac arrest, secondary to opioid intoxication.
4. Arrested, jailed, or imprisoned patients.
5. Inappropriate for the study per judgement of research team.
18 Years
ALL
No
Sponsors
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Purdue Pharma LP
INDUSTRY
Responsible Party
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Other Identifiers
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NAL4001
Identifier Type: -
Identifier Source: org_study_id
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