简体中文|English
检索试验 按国家、省（市）统计 按疾病代码统计 按试验实施单位统计 按试验主办单位统计 按经费或物资来源统计 按征募研究对象情况统计 按注册状态统计 按干预措施统计 按伦理委员会统计 按研究类型统计
利用口服凍晶口溶錠抗利尿劑 (MINIRIN Melt, 免尿寧 口溶片, 每天60微克)治療已接受經尿道前列腺手術後，但仍然持續受夜尿影響的男性患者，以改善其睡眠質素的研究
下载XML文档

注册号：

Registration number：

 ChiCTR-IPR-15007055 

最近更新日期：

Date of Last Refreshed on：

 2016-06-18 20:08:17 

注册时间：

Date of Registration：

 2015-06-09 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

利用口服凍晶口溶錠抗利尿劑 (MINIRIN Melt, 免尿寧 口溶片, 每天60微克)治療已接受經尿道前列腺手術後，但仍然持續受夜尿影響的男性患者，以改善其睡眠質素的研究

Public title：

The relationship between treatment for persistent nocturia in men following transurethral prostate surgery by Desmopressin Acetate Sublingual Wafer Oral Disintegration Formulation (Minirin Melt? 60 μg) and improvement of sleep quality

注册题目简写：

English Acronym：

研究课题的正式科学名称：

利用口服凍晶口溶錠抗利尿劑 (MINIRIN Melt, 免尿寧口溶片, 每天60微克)治療已接受經尿道前列腺手術後，但仍然持續受夜尿影響的男性患者，以改善其睡眠質素的研究

Scientific title：

The relationship between treatment for persistent nocturia in men following transurethral prostate surgery by Desmopressin Acetate Sublingual Wafer Oral Disintegration Formulation (Minirin Melt 60 μg) and improvement of sleep quality

研究课题代号(代码)：

Study subject ID：

 CRE-2013.539

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：

CUHK_CCT00455

申请注册联系人：

Jenny YIP 

研究负责人：

CHAN Chi Kwok 

Applicant：

Jenny YIP 

Study leader：

CHAN Chi Kwok 

申请注册联系人电话：

Applicant telephone：

 +852 26321663

研究负责人电话：

Study leader's
telephone：

+852 26322211

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：

 siuying@surgery.cuhk.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

 chanck@surgery.cuhk.edu.hk

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

 https://www2.ccrb.cuhk.edu.hk/registry/public/294

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

 https://www2.ccrb.cuhk.edu.hk/registry/public/294

申请注册联系人通讯地址：

Rm 02B06, Main Clinical Block and Trauma Centre, PWH

研究负责人通讯地址：

4/F, Clinical Science Building, Prince of Wales Hospital

Applicant address：

Rm 02B06, Main Clinical Block and Trauma Centre, PWH

Study leader's address：

4/F, Clinical Science Building, Prince of Wales Hospital

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

The Chinese University of Hong Kong

Applicant's institution：

The Chinese University of Hong Kong

研究负责人所在单位：

Prince of Wales Hospital; The Chinese University of Hong Kong

Affiliation of the Leader：

Prince of Wales Hospital; The Chinese University of Hong Kong

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：

 CRE2013.539

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：

Joint CUHK-NTEC Clinical Research Ethics Committee

Name of the ethic committee：

Joint CUHK-NTEC Clinical Research Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2014-01-09 00:00:00

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：

The Chinese University of Hong Kong

Primary sponsor：

The Chinese University of Hong Kong

研究实施负责（组长）单位地址：

The Chinese University of Hong Kong

Primary sponsor's address：

The Chinese University of Hong Kong

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

The Chinese University of Hong Kong

Source(s) of funding：

The Chinese University of Hong Kong

研究疾病：

夜尿  

Target disease：

Noctura

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：

4

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

利用口服凍晶口溶錠抗利尿劑 (MINIRIN Melt, 免尿寧口溶片, 每天60微克)治療已接受經尿道前列腺手術後，但仍然持續受夜尿影響的男性患者，以改善其睡眠質素  

Objectives of Study：

The relationship between treatment for persistent nocturia in men following transurethral prostate surgery by Desmopressin Acetate Sublingual Wafer Oral Disintegration Formulation (Minirin Melt 60 μg) and improvement of sleep quality.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

Inclusion criteria

排除标准：

1. Evidence suggestive of significant bladder outlet obstruction: peak uroflow < 4 mL/sec on a void of >=125 mL, or a PVR of >=300 mL;
2. Use of clean intermittent self-catheterization at home
3. Surgical treatment (e.g. TURP) of bladder outlet obstruction/benign prostate hyperplasia <=3 months before entry into the study
4. Genitourinary cancer, including active prostate cancer with ongoing surgical or radiation treatment, or the need of treatment, or bladder cancer, or persistent unexplained hematuria;
5. Having Parkinson's disease with an uncontrolled tremor (as such diseases will invalidate wrist actigraphy);
6. Poorly controlled congestive heart failure as evidenced on physical examination;
7. Poorly controlled diabetes mellitus with either hemoglobin A1c of >=7.5 or a random glucose >=12 mmol/L within last 3 months
8. Unstable health conditions expected to result in death or hospitalization within 3 months, as assessed by principal investigator (PI) or Site PI;
9. Allergic to Desmopressin;
10. Previous spinal cord injury;
11. Currently on dialysis or in consideration for dialysis due to end stage renal disease;
12. More than 3 urinary tract infections within the last 12 months;
13. Unstable dose of diuretic within the past 3 months;
14. Has an artificial urinary sphincter;
15. Impaired mental status;
16. Nocturia due to well-defined causes of increased urinary frequency which require specific management, such as multiple sclerosis, diabetes insipidus, or polydipsia.
17. Subjects with history of frequent / repeated hyponatraemia;
18. Subjects with uncontrolled hypertension, clinically relevant cardiac failure, renal or hepatic disease, known alcohol or drug abuse, other investigational drugs taken in the past 30 days;
19. Subjects with any history of clinically relevant psychiatric disorders within the 24 months preceding enrollment in the trial;
20. Subjects with work or lifestyle factors potentially interfering with regular night-time sleep (e.g., shift workers);
21. Subjects who have already received desmopressin for treatment of other conditions e.g. diabetes insipidus;
22. Subjects who have received new (within 3 months of screening) prescription of sedative/hypnotic medications for sleep disorders, selective serotonin and mixed norepinephrine/serotonin reuptake inhibitors;
23. Unable to give informed consent;
24. Currently participating into other investigational research study during the screening and study period.

Exclusion criteria：

1. Evidence suggestive of significant bladder outlet obstruction: peak uroflow < 4 mL/sec on a void of >=125 mL, or a PVR of >=300 mL;
2. Use of clean intermittent self-catheterization at home
3. Surgical treatment (e.g. TURP) of bladder outlet obstruction/benign prostate hyperplasia <=3 months before entry into the study
4. Genitourinary cancer, including active prostate cancer with ongoing surgical or radiation treatment, or the need of treatment, or bladder cancer, or persistent unexplained hematuria;
5. Having Parkinson's disease with an uncontrolled tremor (as such diseases will invalidate wrist actigraphy);
6. Poorly controlled congestive heart failure as evidenced on physical examination;
7. Poorly controlled diabetes mellitus with either hemoglobin A1c of >=7.5 or a random glucose >=12 mmol/L within last 3 months
8. Unstable health conditions expected to result in death or hospitalization within 3 months, as assessed by principal investigator (PI) or Site PI;
9. Allergic to Desmopressin;
10. Previous spinal cord injury;
11. Currently on dialysis or in consideration for dialysis due to end stage renal disease;
12. More than 3 urinary tract infections within the last 12 months;
13. Unstable dose of diuretic within the past 3 months;
14. Has an artificial urinary sphincter;
15. Impaired mental status;
16. Nocturia due to well-defined causes of increased urinary frequency which require specific management, such as multiple sclerosis, diabetes insipidus, or polydipsia.
17. Subjects with history of frequent / repeated hyponatraemia;
18. Subjects with uncontrolled hypertension, clinically relevant cardiac failure, renal or hepatic disease, known alcohol or drug abuse, other investigational drugs taken in the past 30 days;
19. Subjects with any history of clinically relevant psychiatric disorders within the 24 months preceding enrollment in the trial;
20. Subjects with work or lifestyle factors potentially interfering with regular night-time sleep (e.g., shift workers);
21. Subjects who have already received desmopressin for treatment of other conditions e.g. diabetes insipidus;
22. Subjects who have received new (within 3 months of screening) prescription of sedative/hypnotic medications for sleep disorders, selective serotonin and mixed norepinephrine/serotonin reuptake inhibitors;
23. Unable to give informed consent;
24. Currently participating into other investigational research study during the screening and study period.

研究实施时间：

Study execute time：

从 From 1990-01-01 00:00:00至 To 1990-01-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2015-06-23 00:00:00 至 To 1990-01-01 00:00:00

干预措施：

Interventions：

组别：

Two groups

样本量：

 120

Group：

Two groups

Sample size：

干预措施：

Minirin Melt versus placebo, 60mcg before bed, 4 weeks, respectively

干预措施代码：

Intervention：

Minirin Melt versus placebo, 60mcg before bed, 4 weeks, respectively

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中國

省(直辖市)：

 香港特別行政區 

市(区县)：

  

Country：

China

Province：

Hong Kong SAR

City：

单位(医院)：

 Prince of Wales Hospital; The Chinese University of Hong Kong 

单位级别：

 Prince of Wales Hospital; The Chinese University of Hong Kong 

Institution
hospital：

Prince of Wales Hospital; The Chinese University of Hong Kong

Level of the institution：

Prince of Wales Hospital; The Chinese University of Hong Kong

测量指标：

Outcomes：

指标中文名：

Initial period of undisturbed sleep (i.e. hours of first undisturbed sleep, HUS) at baseline & end of study

指标类型：

主要指标

Outcome：

Initial period of undisturbed sleep (i.e. hours of first undisturbed sleep, HUS) at baseline & end of study

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Mean number of nocturnal voids (Nocturia episodes) at baseline & end of study; Adverse event, mainly hyponatraemia for the entire study period

指标类型：

主要指标

Outcome：

Mean number of nocturnal voids (Nocturia episodes) at baseline & end of study; Adverse event, mainly hyponatraemia for the entire study period

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

diuresis (nocturnal urine volume) at baseline & end of study

指标类型：

次要指标

Outcome：

diuresis (nocturnal urine volume) at baseline & end of study

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

NP index (NPI; nocturnal urine volume/24-hour urine volume [%]) at baseline & end of study

指标类型：

次要指标

Outcome：

NP index (NPI; nocturnal urine volume/24-hour urine volume [%]) at baseline & end of study

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Sleep quality at baseline & end of study

指标类型：

次要指标

Outcome：

Sleep quality at baseline & end of study

Type：

Secondary 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：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 40 岁 years
最大 Max age 75 岁 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）：

Randomization number generated

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

Randomization number generated

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

盲法：

Double-blind

Blinding：

Double-blind

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

是Yes

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）：

Not stated

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

Not stated

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：

Not stated

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

Not stated

数据与安全监察委员会：

Data and Safety Monitoring Committee：

注册人：

Name of Registration：

  2016-06-18 20:08:17
返回列表
欢迎访问WHO国际临床试验注册平台 Clinical Trials Hong Kong

中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

Copyright(c) (2005 - 2023) Chictr.org.cn.All rights reserved. 中国临床试验注册中心 版权所有

蜀ICP备16010396号-9

提示：推荐使用IE8.0以上版本 宽屏显示分辨率下使用系统