NCT05301712View on ClinicalTrials.gov

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

PHASE4CompletedINTERVENTIONAL
Enrollment

446

Participants

Timeline

Start Date

August 7, 2018

Primary Completion Date

October 25, 2022

Study Completion Date

July 10, 2023

Conditions
Stroke, Acute
Interventions
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"

Trial Locations (1)

Unknown

Inha University Hospital, Incheon

All Listed Sponsors
lead

Samjin Pharmaceutical Co., Ltd.

INDUSTRY

NCT05301712 - A Phase 4 Clinical Study to Investigate the Efficacy and Safety of Naloxone HCI IV in Patients With Stroke | Biotech Hunter | Biotech Hunter