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

NCT05301712 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 446

Last updated 2023-08-14

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Samjin Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Dong Keun Hyun, M.D.,Ph.D · Inha University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-07
Primary Completion
2022-10-25
Completion
2023-07-10

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05301712 on ClinicalTrials.gov