Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ChiCTR |
Last refreshed on:
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18 April 2017 |
Main ID: |
ChiCTR-TNC-10000948 |
Date of registration:
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2010-07-27 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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The Application of Overactive Bladder Symptom Score (OABSS) in Response to Treatment in Chinese Population
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Scientific title:
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The Application of Overactive Bladder Symptom Score (OABSS) in Response to Treatment in Chinese Population |
Date of first enrolment:
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2010-03-01 |
Target sample size:
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1:250; |
Recruitment status: |
Completed |
URL:
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http://www.chictr.org.cn/showproj.aspx?proj=8590 |
Study type:
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Interventional study |
Study design:
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historical control
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Phase:
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Post-market
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Countries of recruitment
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China
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Contacts
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Name:
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Jianlong Wang
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Address:
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No.1, Dahua Road, Dongdan, Dongcheng District, Beijing, China
100730
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Telephone:
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+86 13488695786 |
Email:
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wjlspplaaa@sina.com |
Affiliation:
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Beijing Hospital |
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Name:
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Jianye Wang
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Address:
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No.1, Dahua Road, Dongdan, Dongcheng District, Beijing, China
100730
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Telephone:
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+86 13901058760 |
Email:
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wjlspplaaa@sina.com |
Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: At Screening Visit (Week -2)
1. Male or female patient aged >= 18 years;
2. Written informed consent has been obtained;
3. Patient is willing and able to complete the 3-days micturition diary correctly;
4. Symptoms of OAB (including urinary frequency, urgency with or without urge incontinence) for >=3 months;
5. At least 3 episode of urgency with or without incontinence in last 3 days.
At Visit 1 (Week 0)Based on the 3-day micturition diary prior to Visit1:
1. Number of micturition per day>= 8;
2. Number of urgency episodes in 3 days >=3.
Exclusion criteria: At Screening Visit (Week -2)
1. Significant stress incontinence or mixed stress / urge incontinence where stress is the predominant factor as determined by the investigator;
2. Patient with indwelling catheters or practicing intermittent self-catheterization;
3. Evidence of a symptomatic urinary tract infection, chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs;
4. Drug or non-drug treatment for OAB was started, quitted or changed in 4 weeks;
5. Patients under treatment with Solifenacin and the prohibited drugs in Appendix 4;
6. Diabetic neuropathy;
7. Patients who are prohibited from taking Solifenacin as contraindications (See Appendix 5);
8. Any clinical significant condition, which in the opinion of the investigator makes the patient unsuitable for the trial;
9. Participation in any clinical trial in 30 days except for Part 1 of RESORT;
10. Employees of the Astellas Group, third parties associated with the study, or the study site;
11. Pregnant women or women ready to pregnant.
Age minimum:
18
Age maximum:
0
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Overactive bladder
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Intervention(s)
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1:Vesicare 5mg-10mg/day Solifenacine;
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Secondary Outcome(s)
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PPBC;IPSSQOL;IPSS;
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Source(s) of Monetary Support
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Astellas Pharmaceuticals (China) Co.,
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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