Status:
COMPLETED
A Phase 4 Clinical Study to Investigate the Efficacy and Safety of Naloxone HCI IV in Patients With Stroke
Lead Sponsor:
Samjin Pharmaceutical Co., Ltd.
Conditions:
Stroke, Acute
Eligibility:
All Genders
19+ years
Phase:
PHASE4
Brief 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. Eligibl...
Eligibility Criteria
Inclusion
- Subjects who are males or females aged ≥19 years
- Patients with a stroke who can administer drugs for clinical trials within 48 hours from stroke onset
- Patients with a NIHSS score of 5-20 or GCS score of 8-13 at screening assessment (In the case of cerebral infarction, the NIHSS is evaluated, and cerebral hemorrhage, the GCS is evaluated.)
- Patients with a mRS(Modified Rankin Score) \> 2 after stroke and immediately before randomization.
- Patients who or whose representative voluntarily agrees to this study and has given a written informed consent.
Exclusion
- Subjects with medical history of hypersensitivity reaction to investigational product or ingredients.
- Patients with non-narcotic central nerve inhibitors such as barbital drugs or respiratory depression caused by pathological causes.
- Patients who have not passed the wash-out time after administration of opioid analgesics.
- Subjects with Renal dysfunction whose creatine level is more than twice the normal upper limit in screening tests
- Subjects with Liver dysfunction whose AST/ALT level is more than three times the normal upper limit in screening tests.
- Subjects with Systolic blood pressure less than 90 mmHg or more than 220 mmHg during screening.
- Patients with a mRS \> 2 before stroke onset.
- Patients with a history of epilepsy.
- Patients with myocardial infarction within 1 month.
- Pregnant or lactating women
- Patients who have passed more than 48 hours since the onset of symptoms.
- Subjects who received other therapeutic investigational product within the last 30 days.
- Patients who transient ischemic attack.
- Patients whose life expectancy is less than 3 months due to comorbidities other than stroke
- Thrombolysis (including non-drug treatments such as thrombolytic drugs and mechanical procedures used in thrombolysis) or extraventricular drainage (surgical treatment) has been performed or is scheduled to be performed.
- Thrombolytic agent used in thrombolysis\[ex. Streptokinase, Alteplase, Anistreplase, Urokinase, Reteplase, Tenecteplase, Tissue-plasminogen activator (t-PA), Single-chain urokinase-type plasminogen activator (Scu-PA), Lanoteplase, Monteplase, Plasminogen activator inhibitors (PAI)\]
- Surgical treatment \[ex. mechanical thrombectomy, external ventricular drainage (EVD), extralesional drainage (ELD), decompression\], Subarachnoid hemorrhage (SH), Trauma patients \[ex. SH coiling, traumatic intracranial hemorrhage (ICH)\], Among patients with infarction, patients who need or are scheduled to perform Depressive craniomy.
- Any condition that, in the opinion of the investigator, would inappropriate to participate in the clinical trial
Key Trial Info
Start Date :
August 7 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 10 2023
Estimated Enrollment :
446 Patients enrolled
Trial Details
Trial ID
NCT05301712
Start Date
August 7 2018
End Date
July 10 2023
Last Update
August 14 2023
Active Locations (1)
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1
Inha University Hospital
Incheon, South Korea