NCT05301712

A Phase 4 Clinical Study to Investigate the Efficacy and Safety of Naloxone HCI IV in Patients With Stroke

A Placebo Controlled, Double-blind, Randomized, Multicenter Study to Evaluate the Efficacy and Safety of Naloxone HCl IV in Patients With Stroke

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 446 (actual)
• Sponsor: Samjin Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial was planned for the purpose to re-evaluate the safety and efficacy of naloxone hydrochloride in ischemic cerebral nerve disorders caused by stroke and cerebral hemorrhage. Eligible subjects will be randomized to the naloxone hydrochloride group or placebo group at 1:1 ratio. Also, factors, such as disease subtype and severity, which might impact the efficacy endpoints will be used to stratify. \- Stratification factor: cerebral infarction (NIHSS 5-15 points or 16-20 points) or cerebral hemorrhage Administration of investigational product should be started within 48 hours from the onset of symptoms. Subject receive the investigational product 7 consecutive times (for 7 days) in a single dose of intravenous infusion for 24 hours.

Conditions

• Stroke, Acute

Interventions

Type	Name	Description
DRUG	Naloxone hydrochloride 5.0mg/5ml	* Initial dose: 4mg, Intravenous injection * Continuous dose: 8mg(mixed with 1000ml of 5% Dextrose water or saline solution) per day, Intravenous infusion for 7days * Total dose: 4mg+8mg/day\*7=60mg
DRUG	Sodium Chloride 45mg/5ml	* Initial dose: 4ml, Intravenous injection * Continuous dose: 8ml (mixed with 1000ml of 5% Dextrose water or saline solution) per day, Intravenous infusion for 7days * Total dose: 4ml+8ml/day\*7=60ml

Timeline

• Start date: 2018-08-07
• Primary completion: 2022-10-25
• Completion: 2023-07-10
• First posted: 2022-03-31
• Last updated: 2023-08-14

Locations

1 site across 1 country: South Korea