- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01851759
Methanesulfonic Acid Cinepazide Injection for Treatment of Acute Cerebral Infarction
A Random, Double-blind, Placebo- Controlled and Dose-finding, Multi-center, Phase II Clinical Trial of Methanesulfonic Acid Cinepazide Injection for Treatment of Acute Cerebral Infarction
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Tipo di studio
Iscrizione (Anticipato)
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
-
-
Shaanxi
-
Xi'an, Shaanxi, Cina, 710032
- Xijing Hospital
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-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Age between 40 and 75 years old,male/ female;
- The clinical diagnosis of first onset patients with anterior circulation infarction or who have suffered from stroke in history and complete recover from neurologic impairment (mRS score <2 before this disease)
- Patients is proved by head skull CT and cerebral hemorrhage was excluded;
- course of disease≤72h,the NIHSS score is ≥7 and ≤22;
- Patients who voluntarily sign written informed consent. -
Exclusion Criteria:
- Patients who suffer from cerebral infarction accompanied by disorder of consciousness, posterior circulation infarction, lacunar infarction and transient ischemic attack.
- Patients who suffer from brain arteritis, brain tumor, brain injury, intracranial infection, brain parasitic disease, and so on . Patients who suffer from cardiac diseases such as rheumatic heart disease, coronary heart disease with atrial fibrillation .
- Patients who suffer from severe complications, and expected survival period is within three months.
- Patients require thrombolysis, anticoagulation, anti- fibrosis treatment .
- Patients who suffer from serious brain artery stenosis that should go through interventional therapy .
- Patients whose white blood cells or neutrophils is below the lower limit of the normal reference value .
- Patients who have bleeding tendency or suffered from serious bleeding in 3 months.
- Patients who have severe cardiac, liver and kidney disease, or whose kidney and liver function tests was abnormal(ALT,AST≥1.5 times of upper normal limit,Cr>upper normal limit).
- Patients who have complications of malignant tumor, serious or progressive disease in blood, digestion or other system.
- Patients who have complications of mental illness un can not or do not want willing to cooperate .
- Doubt or does have alcohol, drug abuse history
- Allergic constitution or allergic to the test drug ingredients .
- Pregnancy and lactation women or those who has a recent fertility plan
- Patients who have participated in other clinical experiments three months before this test.
- The patients who is unsuitable to participate in the clinical test in the view of researchers
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: Cinepazide, Stroke, Injection
Test drug:Methanesulfonic acid cinepazide injection(5ml/125mg)
|
2 branches of Methanesulfonic acid cinepazide injection were matched into 250 ml 0.9% sodium chloride injection, iv gtt, speed is 100ml/h, once per day. 1 branch of simulation agent of Methanesulfonic acid cinepazide injection was matched into 250 ml 0.9% sodium chloride injection, iv gtt, speed is 100ml/h, once per day.
Altri nomi:
|
Comparatore placebo: palcebo,Stroke,Injection
Placebo:simulation agent of Methanesulfonic acid cinepazide injection(5ml sterile water for injection)
|
2 branches of simulation agent of Methanesulfonic acid cinepazide injection were matched into 250 ml 0.9% sodium chloride injection, iv gtt, speed is 100ml/h, once per day. 1 branch of simulation agent of Methanesulfonic acid cinepazide injection were matched into 250 ml 0.9% sodium chloride injection, iv gtt, speed is 100ml/h, once per day.
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
---|---|
modified Rankin scale
Lasso di tempo: 3 month
|
3 month
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
---|---|
Barthel index
Lasso di tempo: 3 month
|
3 month
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Gang Zhao, Doctor, Xijing Hospital
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
- Ischemia
- Processi patologici
- Necrosi
- Malattia cardiovascolare
- Malattie vascolari
- Disturbi cerebrovascolari
- Malattie del cervello
- Malattie del sistema nervoso centrale
- Malattie del sistema nervoso
- Ischemia cerebrale
- Ictus
- Infarto cerebrale
- Infarto
- Ictus ischemico
- Infarto cerebrale
- Agenti vasodilatatori
- Cinepazide
Altri numeri di identificazione dello studio
- xijing005
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