今天是:2021-07-24 星期六

连续口服沙利度胺片安全耐受性和药代动力学临床试验研究
下载XML文档

注册号:

Registration number:

ChiCTR-ONRC-10000858 

最近更新日期:

Date of Last Refreshed on:

2016-10-07 

注册时间:

Date of Registration:

2010-04-28 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

连续口服沙利度胺片安全耐受性和药代动力学临床试验研究 

Public title:

Research on safety tolerance and pharmacokinetics of oral muti-dose Thalidomide 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

连续口服沙利度胺片安全耐受性和药代动力学临床试验研究 

Scientific title:

Research on safety tolerance and pharmacokinetics of oral muti-dose Thalidomide 

研究课题代号(代码):

Study subject ID:

2008L03398C-1、2008L03398C-2 

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:

 

申请注册联系人:

白楠 

研究负责人:

王睿 

Applicant:

Bai Nan 

Study leader:

Wang Rui 

申请注册联系人电话:

Applicant telephone:

+86 010 66937908 

研究负责人电话:

Study leader's telephone:

+86 010 66939409 

申请注册联系人传真 :

Applicant Fax:

 

研究负责人传真:

Study leader's fax:

 

申请注册联系人电子邮件:

Applicant E-mail:

bainan82@126.com 

研究负责人电子邮件:

Study leader's E-mail:

wangrui301@vip.sina.com 

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):

 

申请注册联系人通讯地址:

北京市复兴路28号解放军总医院东病房楼3层I期临床试验病房 

研究负责人通讯地址:

北京市复兴路28号解放军总医院东病房楼3层I期临床试验病房 

Applicant address:

28 Fuxing Road, Chinese PLA General Hospital, Beijing 

Study leader's address:

28 Fuxing Road, Chinese PLA General Hospital, Beijing 

申请注册联系人邮政编码:

Applicant postcode:

100853 

研究负责人邮政编码:

Study leader's postcode:

100853 

申请人所在单位:

解放军总医院 

Applicant's institution:

Chinese PLA General Hospital 

是否获伦理委员会批准:

否 

Approved by ethic committee:

NO 

伦理委员会批件文号:

Approved No. of ethic committee:

 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

 

Name of the ethic committee:

 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-26 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

 

研究实施负责(组长)单位:

中国人民解放军总医院 

Primary sponsor:

Chinese PLA General Hospital 

研究实施负责(组长)单位地址:

北京市复兴路28号 

Primary sponsor's address:

28 Fuxing Road, Chinese PLA General Hospital, Beijing 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

江苏

市(区县):

常州

Country:

China

Province:

Jiangsu

City:

Changzhou

单位(医院):

常州制药厂有限公司

具体地址:

江苏省常州市劳动东路518

Institution
hospital:

Changzhou Pharmaceutical Factory

Address:

518 East Labor Road, Changzhou, Jiangsu province

经费或物资来源:

常州制药厂有限公司 

Source(s) of funding:

Changzhou Pharmaceutical Factory 

研究疾病:

强直性脊柱炎 

Target disease:

Ankylosing Spondylitis 

研究疾病代码:

 

Target disease code:

 

研究类型:

观察性研究 

Study type:

Observational study 

研究所处阶段:

I期临床试验 

Study phase:

研究目的:

1.研究在中国健康男性受试者中连续口服沙利度胺片药代动力学 2.研究在患者中连续口服Tha片和联用双氯芬酸钠肠溶片药代动力学特点。 

Objectives of Study:

To study the pharmacokinetics clinical trial of oral muti-dose Thalidomide and Diclofenac sodium enteric-coated tablets in patients. 

药物成份或治疗方案详述:

沙利度胺 谷氨酸衍生物 

Description for medicine or protocol of treatment in detail:

Thalidomide Glutamic acid derivatives 

研究设计:

非随机对照试验 

Study design:

Non randomized control 

纳入标准:

2008L03398C-1: (健康受试者) 1.充分了解试验内容与可能出现的不良反应后,自愿参加本项临床试验,书面签署知情同意书。 2.健康男性,35-45周岁。同意并承诺在筛选期、整个研究期间和最后一次应用研究药物后至少1年内使用医学上可接受的方式进行避孕。 3.体重在正常范围内,并且体重≥50kg。体重指数(BMI)在19.0至24.0 kg/m2范围内。 4.通过询问病史、体格检查、生命体征、临床实验室检查、胸部X射线检查、12导心电图、结核菌素试验等证实身体健康,并详细询问计划生育史。 5.至少4周内未服用其它任何药物。 6.无心、肝、肾、消化道、神经系统、代谢异常等病史。 7.无药物和食物过敏史,无烟酒嗜好。 8.具有很大可能依从于并完成研究。 2008L03398C-2:(强直性脊柱炎) 1.18-45周岁,并承诺在筛选期、整个研究期间(包括随访期)和最后一次应用研究药物后至少1年内使用医学上可接受的方式进行避孕。 2.按照诊断AS的1966年纽约标准(见附件1),根据最近1年内拍摄的骶髂关节X片,确诊为AS。 3.入选期间患活动性AS,定义为晨僵的持续时间和强度在视觉模拟尺度(VAS)的均值≥30并满足下述中的2项:受试者的VAS总体评估≥30;夜晚和总体背部疼痛的平均VAS≥30;或BathAS功能指数(BASFI)≥30(所有分数在0-100刻度内)。 4.筛查时如果受试者正在使用物理治疗如针灸、理疗、红外线照射、激光治疗等,则治疗至少已稳定2周。 5.筛查时受试者正在口服双氯芬酸钠药物入组前7天改用由研究者提供的双氯芬酸钠肠溶片,如受试者正在口服除双氯芬酸钠药物外其他NSAIDs药物,则入组前7天改用由研究者提供的成双氯芬酸钠肠溶片。 6.如患者正在用病情缓解药(如柳氮磺吡啶,甲氨蝶呤等)应停药至少1个月以上。 

Inclusion criteria

2008L03398C-1: (healthy volunteer) 1. The voluntary to participate in clinical trials must be fully understand the test content and possible adverse reactions,and signed informed consent; 2. Healthy male, aged 35 to 45 years of age, must agree and commit to use a medically acceptable form of contraception during the screening period,throughout the study (including follow-up), and for at least 1 year after the last dose of test article; 3. Body mass index (BMI) in the range of 19.0 to 24.0 kg/m2 and body weight >=50 kg; 4. Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, chest x-ray examination, and 12-lead electrocardiogram (ECG); 5. Without taking any other medicines at least 4 weeks; 6. Without heart, liver, kidney, gastrointestinal tract, nervous system, metabolic disorders and other medical history; 7. No history of drug and food allergies, no tobacco and alcohol habits; 8. Have a high probability for compliance with and completion of the study. 2008L03398C-2:(Ankylosing spondylitis) 1. Patients with 18 to 45 years of age, must agree and commit to use a medically acceptable form of contraception during the screening period, throughout the study (including follow-up), and for at least 1 year after the last dose of test article; 2. Diagnosis of AS according to the 1966 New York standards (see Annex 1), according to a recent shot of sacroiliac joint X film in 1 year, diagnosed as AS; 3. Selected patients during the active AS, defined as the duration of morning stiffness and strength in the mean of the visual analog scale (VAS) >=30 and to meet the following: VAS overall assessment of subjects >=30; The average pain VAS of night and the whole back >=30; or BathAS Functional Index (BASFI) >=30 (all scores within the 0-100 scale); 4. If screening of subjects is being used physical therapy such as acupuncture, physical therapy, infrared radiation, laser therapy, the treatment has been stable at least 2 weeks; 5. Screening of subjects into groups is oral diclofenac medication 7 days before the switch provided by the researchers of diclofenac sodium enteric-coated tablet, if the subjects are oral NSAIDs drugs other than diclofenac drugs, then 7 days before enrollment provided by the researchers into the use of diclofenac sodium enteric-coated tablets; 6. If patients are using remission drugs (such as sulfasalazine, methotrexate, etc.) should be discontinued at least 1 month. 

排除标准:

2008L03398C-1: (健康受试者) 1.通过询问病史、体格检查和相关实验室检查,有证据表明受试者患有任何疾病和结核病家族史、既往史或现病史者;在审核研究前的实验室资料和全面体检后,发现受试者存在有临床意义的异常。 2.筛选前6个月内有过较严重的感染(如肝炎、肺炎和肾盂肾炎)者,曾患有慢性或反复发作的全身或局部感染。 3.有个人或家族免疫性疾病史或有过敏史者。 4.直接参与本临床试验单位的研究人员及其家属。 5.受试者在研究前一个月内曾经献血,或打算在研究期间或研究结束后一个月内献血; 6.受试者每周饮用超过28单位的酒精(1单位=285ml啤酒或25ml烈酒或1玻璃杯葡萄酒);受试者每日吸烟超过5只香烟(或等量的烟草);研究第1天前48小时内饮用酒精饮料。 7.尿药筛查结果阳性[如安非他明、巴比妥、苯二氮卓、大麻、可卡因、美沙酮、鸦片和苯环己哌啶(PCP)]。 8.筛选期前3个月内接受过研究药物,给予试验药物前4周内,受试者正在应用或曾经应用过任何医生处方的或自己购买的药物(包括皮质激素类药物等)。 9.由于任何理由,研究人员认为该受试者不可能完成本研究。 2008L03398C-2:(强直性脊柱炎) 1.筛查时患者正在服用糖皮质激素类药物。 2.现患心、肝、肾、血液、内分泌系统疾病或有上述病史者以及有多发性硬化病史者。 3.孕妇、哺乳期妇女。 4.以前接受过抗TNF药物治疗或3个月内参加过任何药物临床试验。 5.筛选前6个月内有过较严重的感染(如肝炎、肺炎和肾盂肾炎)者,曾患有慢性或反复发作的全身或局部感染。 6.乙肝表面抗原、丙肝或HIV抗体检查阳性者,或既往有病毒性肝炎病史者。 7.现患或有活动性结核病史者,有X-线胸片发现怀疑有结核者,3个月内有结核病密切接触史者,胸片检查阴性但PPD检查怀疑阳性者(48~72小时后测定皮肤硬结直径10mm)。 8.受试者在研究前三个月内曾经献血,或打算在研究期间或研究结束后一个月内献血; 9.受试者每日吸烟超过5支香烟(或等量的烟草)和酗酒者。 10.由于任何理由,研究人员认为该受试者不可能完成本研究。 

Exclusion criteria:

2008L03398C-1:(healthy volunteer) 1. Presence or history of any disorder that may prevent the successful completion of the study; 2. Serious infection (infection associated with hospitalization and/or parenteral antimicrobial agents) within 6 months before test article administration or active infection at screening; 3.Personal or family history of autoimmune disease or a history of allergies; 4. Directly involved in the clinical trials research unit and their families; 5. Subjects had blood donation within one month before the study, or intended to have blood donation in the end of the study or during the study period within one month; 6. Subjects drinking more than 28 units of alcohol (1 unit = 285ml of beer or 25ml spirits or a glass of wine)weekly; subjects smoking more than five cigarettes per day (or the equivalent amount of tobacco);drinking alcohol in the48 hours before the first day of study; 7.Positive findings of urine drug screen (eg, amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, opiates, and phencyclidine [PCP]); 8. 3 months before screening had received study drug, study drug was given to the first 4 weeks, the subjects being applied or have applied any prescription or buy their own drugs (including steroid drugs, etc.) 9. For any reason, the researchers believe that the subjects can not complete this study. 2008L03398C-2:(Ankylosing Spondylitis) 

研究实施时间:

Study execute time:

From2010-05-01To 2010-10-31 

征募观察对象时间:

Recruiting time:

From2010-05-10To 2010-05-20 

干预措施:

Interventions:

组别:

1

样本量:

15

Group:

Group A

Sample size:

干预措施:

连续口服沙利度胺片

干预措施代码:

Intervention:

Muti-dose Thalidomide

Intervention code:

组别:

2

样本量:

12

Group:

GroupB

Sample size:

干预措施:

连续口服沙利度胺片联用双氯芬酸钠肠溶片

干预措施代码:

Intervention:

Muti-dose Thalidomide and Diclofenac sodium enteric-coated tablets

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

中国人民解放军总医院 

单位级别:

三甲 

Institution
hospital:

Chinese PLA General Hospital  

Level of the institution:

Tertiary A Hopital 

测量指标:

Outcomes:

指标中文名:

血药浓度

指标类型:

主要指标 

Outcome:

Plasma concentration

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

征募研究对象情况:

Recruiting status:

结束

Completed

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 45 years

性别:

男女均可

Gender:

Both

随机方法(请说明由何人用什么方法产生随机序列):

NA

Randomization Procedure (please state who generates the random number sequence and by what method):

NA

盲法:

NA

Blinding:

NA

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

否No

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):

中国人民解放军总医院I期临床试验病房

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):

Chinese PLA General Hospital

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:

中国人民解放军总医院统计教研室

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

Chinese PLA General Hospital

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2010-04-28
返回列表