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托特罗定和坦索罗辛联合治疗良性前列腺增生的临床研究
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注册号:

Registration number:

ChiCTR-TRC-09000596 

最近更新日期:

Date of Last Refreshed on:

2015-05-16 

注册时间:

Date of Registration:

2009-11-27 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

托特罗定和坦索罗辛联合治疗良性前列腺增生的临床研究 

Public title:

The therapeutic effect of combined use of tolterodine and tamsulosin for benign prostate hyperplasia 

研究课题的正式科学名称:

托特罗定和坦索罗辛联合治疗良性前列腺增生的临床研究 

Scientific title:

The therapeutic effect of combined use of tolterodine and tamsulosin for benign prostate hyperplasia 

研究课题代号(代码):

Study subject ID:

2007-3114 

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:

蔡建良 

研究负责人:

蔡建良 

Applicant:

Jianliang Cai 

Study leader:

Jianliang Cai 

申请注册联系人电话:

Applicant telephone:

+86 010 68875731-6378 

研究负责人电话:

Study leader's telephone:

+86 010 68875731-6378 

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:

jlcai@bjmu.edu.cn 

研究负责人电子邮件:

Study leader's E-mail:

jlcai@bjmu.edu.cn 

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:

北京市石景山区晋元庄路9号 

研究负责人通讯地址:

北京市石景山区晋元庄路9号 

Applicant address:

9 Jinyuanzhuang street, Shijingshan District, Beijing, China 

Study leader's address:

9 Jinyuanzhuang street, Shijingshan District, Beijing, China 

申请注册联系人邮政编码:

Applicant postcode:

100144 

研究负责人邮政编码:

Study leader's postcode:

100144 

申请人所在单位:

北京大学首钢医院泌尿外科 

Applicant's institution:

Department of Urology, Peking University Shougang Hospital 

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

2008717 

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:

北京大学首钢医院医学伦理委员会 

Name of the ethic committee:

Medical Ethic Committee of Peking University Shougang Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2008-07-17 

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:

北京大学首钢医院 

Primary sponsor:

Peking University Shougang Hospital 

研究实施负责(组长)单位地址:

北京市石景山区晋元庄路9号 

Primary sponsor's address:

9 Jinyuanzhuang street, Shijingshan District, Beijing, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

北京市卫生局

具体地址:

北京市宣武区枣林前街70号

Institution
hospital:

Beijing City Health Administration

Address:

70 Zaolinqian Street, Xuanwu District, Beijing, China

经费或物资来源:

首都医学发展基金 

Source(s) of funding:

Capital Medical Development Fund 

研究疾病:

良性前列腺增生 

Target disease:

Benign Prostate Hyperplasia 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

上市后药物 

Study phase:

Post-market 

研究目的:

探索联合应用M-受体、α1-受体阻滞剂干扰良性前列腺增生患者前列腺的副交感神经、交感神经支配体系后产生的全方位的治疗作用,尤其是患者增大前列腺的体积变化。 

Objectives of Study:

To investigate the therapeutic effect of the combination use of M-receptor and alpha 1-receptor blockers for human benign prostate hyperplasia by interfering both parasympathetic intervation and sympathetic intervation, especially the volume reduction of the enlarged prostate of patients. 

药物成份或治疗方案详述:

安慰剂1 淀粉 托特罗定 酒石酸托特罗定 安慰剂2 淀粉 坦索罗辛 盐酸坦洛辛 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照试验 

Study design:

Randomized parallel controlled trial 

纳入标准:

placebo 1 starch placebo 2 starch Tolterodine tolterodine tartrate Tamsulosin 

Inclusion criteria

1. Male, 50 years and older; 2. Diagnosed as benigh prostate hyperplasia(BPH)and had a prostate volume >=25ml; 3. The total international prostate symptom score of 12 or higher and, the international prostate symptom score quantity-of-life item score of 3 or higher; 4. Voluntarily attend this study and sign the informed consent. 

排除标准:

1、神经源性膀胱病变者。 2、有除BPH外其他下尿路梗阻原因者。 3、排尿后膀胱残余尿≥200ml和/或肾功能异常,最大尿流率<5ml/s者。 4、曾多次发生急性尿潴留,并长时间佩带导尿管或自行导尿者。 5、曾接受征对前列腺的侵入性治疗者。 6、血清PSA≥10.0ng/ml,或已确诊为前列腺癌者。 7、2周内使用过α1-受体阻滞剂,1月内使用过抗胆碱药物、沙巴棕药物治疗者(如要求进入实验,需分别经过2周、1月时间的洗脱期)。 8、3月内使用过5α-还原酶抑制剂治疗者(如要求进入实验,需经过3月时间的洗脱期)。 9、有口服托特罗定、坦索罗辛其他禁忌症者。 10、有严重的全身性疾患或精神疾患,不宜作为本课题研究对象者。 11、由于患者心理、社会、家庭及地理原因,不能配合定期随访观察者。 12、患者或家属不愿签署知情同意书或不合作者。 13、研究医生认为有任何不适宜入选情况者。 

Exclusion criteria:

1. Suffered from neurogenic bladder; 2. With other low urinary obstruction causes except benign prostate hyperplasis; 3. Postvoid residual volume >=200ml, abnormal renal function, or maximum urinary flow rate <5ml/s; 4. Suffered from acute urinary retention >=2 times, or have proofs of bladder decompensation; 5. Have received invasive treatments for BPH; 6. Serum PSA>=10.0ng/ml, or diagnosed as carcinoma of prostate; 7. Take alpha 1-antibody block agent within 2 weeks, anticholine drugs or saw palmetto drugs within 1 month (patients who wish to attend the study must perform wash-out for 2 weeks, 1 month, respectively); 8. Used 5 alpha-reducase inhibitor within 3 months (patients wish to attend the study must perform wash-out for 3 month); 9. With other contraindications of tolterodine or tamsulosin; 10. With severe systemic diseases or mental disorder; 11. Cannot insist on regular follow-up for psychological, social, domestic or physical reasons; 12. Unwilling to sign informed consent or refuse to cooperation; 13. With other causes misfit as a volunteer discovered by investigators. 

研究实施时间:

Study execute time:

From2009-12-17To 2011-03-17 

干预措施:

Interventions:

组别:

组A

样本量:

30

Group:

Group A

Sample size:

干预措施:

口服盐酸坦洛辛控释片0.2mg、安慰剂2 4mg,每日各1次

干预措施代码:

Intervention:

receive 0.2mg tamsulosin and 4mg placebo 2, once a day

Intervention code:

组别:

组B

样本量:

30

Group:

Group B

Sample size:

干预措施:

口服酒石酸托特罗定缓释片4mg、安慰剂1 0.2mg,每日各1次

干预措施代码:

Intervention:

receive 4mg tolterodine and 0.2mg placebo 1, once a day

Intervention code:

组别:

组C

样本量:

30

Group:

Group C

Sample size:

干预措施:

口服酒石酸托特罗定控释片4mg、盐酸坦洛辛0.2mg,每日各1次

干预措施代码:

Intervention:

receive 4mg tolterodine and 0.2mg tamsulosin, once a day

Intervention code:

组别:

组D

样本量:

30

Group:

Group D

Sample size:

干预措施:

口服安慰剂1 0.2mg、安慰剂2 4mg,每日各1次

干预措施代码:

Intervention:

received 0.2mg placebo1 and 4mg placebo2, once a day

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):

北京大学首钢医院 

单位级别:

三甲医院 

Institution
hospital:

Peking University Shougang Hospital  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

最大尿流率、平价尿流率

指标类型:

主要指标 

Outcome:

maximum urinary flow rate and average urinary flow rate

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

前列腺体积、前列腺移行带体积和移行带指数

指标类型:

主要指标 

Outcome:

prostate volume, prostate transitional zone volume and transitional zone index

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

IPSS、QOL评分

指标类型:

主要指标 

Outcome:

IPSS and QOL scores

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

残余尿

指标类型:

次要指标 

Outcome:

residual urine

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血清PSA

指标类型:

次要指标 

Outcome:

serum PS

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血压检测

指标类型:

副作用指标 

Outcome:

blood pressure

Type:

Adverse events 

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 50 years
最大 Max age 0 years

性别:

男性

Gender:

Male

随机方法(请说明由何人用什么方法产生随机序列):

随机数字表

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

randomization table

盲法:

志愿受试者 是 研究过程中不知晓自身服药真实情况 参与研究医师 是 研究过程中不知晓研究药物分组具体情况

Blinding:

participant patients: Yes doctors: Yes

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

即时公开/Real time access

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):

北京大学首钢医院

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

Peking University Shougang 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:

北京大学首钢医院

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

Peking University Shougang Hospital

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2009-11-27
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