- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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
연구 개요
상세 설명
연구 유형
등록 (예상)
단계
- 2 단계
연락처 및 위치
연구 장소
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Shaanxi
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Xi'an, Shaanxi, 중국, 710032
- Xijing Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Cinepazide, Stroke, Injection
Test drug:Methanesulfonic acid cinepazide injection(5ml/125mg)
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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.
다른 이름들:
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위약 비교기: palcebo,Stroke,Injection
Placebo:simulation agent of Methanesulfonic acid cinepazide injection(5ml sterile water for injection)
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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.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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modified Rankin scale
기간: 3 month
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3 month
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2차 결과 측정
결과 측정 |
기간 |
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Barthel index
기간: 3 month
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3 month
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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Gang Zhao, Doctor, Xijing Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
허혈성 뇌졸중에 대한 임상 시험
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Institut National de la Santé Et de la Recherche...모병