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注册号: Registration number: |
ChiCTR2500099144 |
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最近更新日期: Date of Last Refreshed on: |
2025-03-19 09:44:12 |
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注册时间: Date of Registration: |
2025-03-19 00:00:00 |
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注册号状态: |
补注册 |
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Registration Status: |
Retrospective registration |
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注册题目: |
地西泮鼻喷雾剂用于癫痫患者的安全性和有效性的真实世界研究 |
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Public title: |
A real-world study of the safety and efficacy of diazepam nasal spray in patients with epilepsy |
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注册题目简写: |
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English Acronym: |
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研究课题的正式科学名称: |
地西泮鼻喷雾剂用于癫痫患者的安全性和有效性的真实世界研究 |
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Scientific title: |
A real-world study of the safety and efficacy of diazepam nasal spray in patients with epilepsy |
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研究课题代号(代码): Study subject ID: |
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在二级注册机构或其它机构的注册号: The registration number of the Partner Registry or other register: |
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申请注册联系人: |
王群 |
研究负责人: |
王群 |
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Applicant: |
Qun Wang |
Study leader: |
Qun Wang |
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申请注册联系人电话: Applicant telephone: |
+86 131 4625 4818 |
研究负责人电话:
Study leader's |
+86 131 4625 4818 |
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申请注册联系人传真 : Applicant Fax: |
研究负责人传真: Study leader's fax: |
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申请注册联系人电子邮件: Applicant E-mail: |
qwang64@163.com |
研究负责人电子邮件: Study leader's E-mail: |
qwang64@163.com |
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申请单位网址(自愿提供): Applicant website(voluntary supply): |
研究负责人网址(自愿提供): Study leader's website(voluntary supply): |
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申请注册联系人通讯地址: |
北京市丰台区南四环西路119号北京天坛医院 |
研究负责人通讯地址: |
北京市丰台区南四环西路119号北京天坛医院 |
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Applicant address: |
119 South Fourth Ring Road West, Fengtai District, Beijing, P.R.China |
Study leader's address: |
119 South Fourth Ring Road West, Fengtai District, Beijing, P.R.China |
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申请注册联系人邮政编码: Applicant postcode: |
100070 |
研究负责人邮政编码: Study leader's postcode: |
100070 |
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申请人所在单位: |
首都医科大学附属北京天坛医院 |
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Applicant's institution: |
Beijing Tiantan Hospital, Capital Medical University |
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研究负责人所在单位: |
首都医科大学附属北京天坛医院 |
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Affiliation of the Leader: |
Beijing Tiantan Hospital, Capital Medical University |
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是否获伦理委员会批准: |
是 |
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Approved by ethic committee: |
Yes |
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伦理委员会批件文号: Approved No. of ethic committee: |
KY2024-041-02 |
伦理委员会批件附件: Approved file of Ethical Committee: |
查看附件View |
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批准本研究的伦理委员会名称: |
首都医科大学附属北京天坛医院医学伦理委员会 |
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Name of the ethic committee: |
IRB of Beijing Tiantan Hospital, CapitaI Medical University |
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伦理委员会批准日期: Date of approved by ethic committee: |
2024-04-12 00:00:00 | ||
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伦理委员会联系人: |
肖淑萍 |
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Contact Name of the ethic committee: |
Shuping Xiao |
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伦理委员会联系地址: |
北京市丰台区南四环西路119号北京天坛医院 |
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Contact Address of the ethic committee: |
Beijing Tiantan Hospital, Capital Medical University, 119 South Fourth Ring Road West, Fengtai District, Beijing, P.R.China |
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伦理委员会联系人电话: Contact phone of the ethic committee: |
+86 10 5997 8555 |
伦理委员会联系人邮箱: Contact email of the ethic committee: |
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研究实施负责(组长)单位: |
首都医科大学附属北京天坛医院 |
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Primary sponsor: |
Beijing Tiantan Hospital, Capital Medical University |
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研究实施负责(组长)单位地址: |
北京市丰台区南四环西路119号北京天坛医院 |
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Primary sponsor's address: |
119 South Fourth Ring Road West, Fengtai District, Beijing, P.R.China |
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试验主办单位(项目批准或申办者): Secondary sponsor: |
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经费或物资来源: |
深圳市康哲药业有限公司(91440300192191146L) |
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Source(s) of funding: |
China Medical System Holdings Limited (91440300192191146L) |
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研究疾病: |
癫痫 |
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Target disease: |
epilepsy |
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研究疾病代码: |
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Target disease code: |
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研究类型: |
观察性研究 |
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Study type: |
Observational study |
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研究所处阶段: |
上市后药物 | ||||||||||||||||||||||
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Study phase: |
4 |
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研究设计: |
队列研究 |
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Study design: |
Cohort study |
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研究目的: |
主要研究目的: 1. 评估真实世界中,地西泮鼻喷雾剂急性治疗癫痫患者癫痫频繁发作的安全性; 次要研究目的: 1. 评估真实世界中,地西泮鼻喷雾剂急性治疗癫痫患者癫痫频繁发作的有效性; 2. 根据基线期收集的患者基线人口学、癫痫病史、癫痫发作频率、癫痫发作类型、用药方案、病因诊断等进行流行病学研究,分析中国诊疗环境下癫痫患者出现丛集性癫痫发作的特征及风险因素。 |
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Objectives of Study: |
Main Objectives: 1. To evaluate the real-world safety of diazepam nasal spray for the acute treatment of frequent seizures in patients with epilepsy; Secondary objectives: 1. To assess the effectiveness of diazepam nasal spray in the acute treatment of frequent seizures in patients with epilepsy in the real world; 2. Epidemiological studies were conducted based on the baseline demography, seizure history, seizure frequency, seizure type, medication regimen, and etiology diagnosis of patients with epilepsy collected during the baseline period to analyze the characteristics and risk factors of cluster seizures in patients with epilepsy in the diagnosis and treatment environment in China. |
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药物成份或治疗方案详述: |
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Description for medicine or protocol of treatment in detail: |
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纳入标准: |
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Inclusion criteria |
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排除标准: |
1. 怀孕、哺乳的女性或 6 个月内有妊娠计划者; 2. 患有较严重(不限于)感染、中毒、营养代谢障碍、内分泌疾病、五官、皮肤、呼吸和循环系统疾病、消化系统疾病、泌尿系统疾病、血液系统疾病、风湿免疫病或神经精神疾病等,研究者认为受试者存在安全隐患或者疾病本身或/和相关治疗会干扰试验进行与评估; 3. 对地西泮或其他苯二氮䓬类药物以及试验药物辅料有过敏史或疑似过敏史; 4. 有药物滥用、精神疾病或酗酒史,不能配合临床研究者; 5. 急性闭角型青光眼患者; 6. 研究者认为不适合参加研究的其他患者。 |
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Exclusion criteria: |
1. Pregnant, breastfeeding females or those who have a pregnancy plan within 6 months; 2. Suffering from serious (not limited to) infection, poisoning, nutritional and metabolic disorders, endocrine diseases, facial diseases, skin, respiratory and circulatory system diseases, digestive system diseases, urinary system diseases, blood system diseases, rheumatic immune diseases or neuropsychiatric diseases, etc., and the investigator believes that the subject has potential safety hazards or the disease itself or/and related treatments will interfere with the conduct and evaluation of the trial; 3. History of allergy or suspected allergy to diazepam or other benzodiazepines and test drug excipients; 4. Those who have a history of drug abuse, mental illness or alcoholism, and cannot cooperate with clinical research; 5. Patients with acute angle-closure glaucoma; 6. Other patients who, in the opinion of the investigator, are not suitable to participate in the study. |
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研究实施时间: Study execute time: |
从 From 2024-09-25 00:00:00至 To 2026-12-31 00:00:00 |
征募观察对象时间: Recruiting time: |
从 From 2024-09-25 00:00:00 至 To 2026-12-31 00:00:00 |
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干预措施: Interventions: |
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研究实施地点: Countries of recruitment and research settings: |
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测量指标: Outcomes: |
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采集人体标本:
Collecting sample(s)
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征募研究对象情况: Recruiting status: |
正在进行 Recruiting |
年龄范围: Participant age: |
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性别: |
男女均可 |
Gender: |
Both |
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随机方法(请说明由何人用什么方法产生随机序列): |
无 |
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Randomization Procedure (please state who generates the random number sequence and by what method): |
None |
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是否公开试验完成后的统计结果: Calculated Results after the Study Completed public access: |
公开/Public |
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盲法: |
无 |
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Blinding: |
None |
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试验完成后的统计结果(上传文件): |
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Calculated Results after
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是否共享原始数据: IPD sharing |
是Yes |
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共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址): |
EDC网络平台名称:医学科研云平台(https://ecrf.linklab.com/#/);本研究预计2026年12月结束,预计2027年6月共享研究成果。 |
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The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url): |
EDC platform: medical research cloud platform (https://ecrf.linklab.com/#/); The study is expected to end in December 2026, and the research results are expected to be shared in June 2027. |
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数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC: |
使用病例记录表(Case Record Form, CRF)记录数据后录入电子采集和管理系统(Electronic Data Capture, EDC)。 |
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Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture: |
Data is recorded using a case record form and entered into an Electronic Data Capture(EDC) and management system. |
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数据与安全监察委员会: Data and Safety Monitoring Committee: |
无/No |