UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011620 |
|---|---|
| Receipt number | R000013590 |
| Scientific Title | Investigation of availability of solifenacin succinate on effect insufficiency cases by b3 receptor agonist -Switching study from mirabegron to solifenacin- |
| Date of disclosure of the study information | 2013/09/02 |
| Last modified on | 2016/12/14 16:24:25 |
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Basic information
Public title
Investigation of availability of solifenacin succinate on effect insufficiency cases by b3 receptor agonist
-Switching study from mirabegron to solifenacin-
Acronym
WATCH (Woman Availability Trial by CHanging mirabegron to solifenacin) Study
Scientific Title
Investigation of availability of solifenacin succinate on effect insufficiency cases by b3 receptor agonist
-Switching study from mirabegron to solifenacin-
Scientific Title:Acronym
WATCH (Woman Availability Trial by CHanging mirabegron to solifenacin) Study
Region
| Japan |
Condition
Condition
Overactive bladder
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigate a drug change efficacy and safety of solifenacin (anticholinergic agent) in female patients with OAB who are insufficient with treatment of mirabegron (b3 agonist).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of total OABSS score from registration to last observation (12weeks later or discontinuation)
Key secondary outcomes
1) Change of QOL score from registration to last observation (12weeks later or discontinuation)
2) Change of contents in frequent volume chart from registration to last observation (12weeks later or discontinuation)
3) Change of residual urine volume from registration to last observation (12weeks later or discontinuation)
4) Adverse events (item and incidence)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
For patients who are insufficient with mirabegron 50mg once a day for more than 8 weeks, 5mg of solifenacin will be orally administered once a day after breakfast for 12 weeks.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1) Female
2) OAB patients who are treated with 50 mg OD of mirabegron for more than 8 weeks before registration.
3) OAB patients (OABSS >=3, urgency score (OABSS) >= 2 and QOL score >=4) in 2 points within 4 weeks before registration and on registration.
4) Patients with hope of drug change
5) Patients from whom we have received written consent.
Key exclusion criteria
1) Patients with taking drugs that have an influence on the urination function.
2) Patients that the malignancy of the lower urinary tract is doubted.
3) Patients that detrusor muscular low activity is doubted.
4) Patients with urethral stricture.
5) Patients that carried out radiotherapy to pelvic part.
6) Patients with active urine tract infection.
7) Patients with urinary tract calculus, interstitial cystitis.
8) Patients with the practice of intermittent self-catheterization.
9) Patients with serious liver dysfunction, kidney dysfunction and heart disease.
10) Patients with polyuria.
11) Contraindicated case of anti-cholinergic agents (solifenacin).
*patients with obstruction of pylorus, duodenum and intestinal tract.
*patients with closure-angle glaucoma.
*patient with gastric atony or intestinal atony.
*patients with myasthenia gravis.
12) Patients with neurogenic bladder.
13) Residual urine volume is more than 100mL.
14) Patients that take solifenacin and other anti-cholinergic agents within 6 months before mirabegron administration.
15) Any other patients that are regarded as unsuitable for this study by the investigator.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Narihito Seki |
Organization
Kyushu Central Hospital of the Mutual Aid Association of Public Scholl Teachers
Division name
Department of Urology
Zip code
Address
Shiobaru3-13-1,Minami-ku, Fukuoka-city, Fukuoka, Japan
TEL
092-541-4936
narihito@kyushu-ctr-hsp.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Narihito Seki |
Organization
Kyushu Central Hospital of the Mutual Aid Association of Public Scholl Teachers
Division name
Department of Urology
Zip code
Address
Shiobaru3-13-1,Minami-ku, Fukuoka-city, Fukuoka, Japan
TEL
092-541-4936
Homepage URL
narihito@kyushu-ctr-hsp.com
Sponsor or person
Institute
Clinical Research Support Center Kyushu
Institute
Department
Personal name
Funding Source
Organization
Astellas Pharma Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
九州大学病院（福岡県）、公立学校共済組合九州中央病院（福岡県）、福岡赤十字病院（福岡県）、医療法人社団 邦生会 高山病院（福岡県）、つのだ泌尿器科クリニック（福岡県）、泌尿器科・皮膚科 かわの医院（福岡県）、泌尿器科いとうクリニック（福岡県）、製鉄記念八幡病院（福岡県）、西南泌尿器科クリニック（福岡県）、北九州市立医療センター（福岡県）、医療法人 原三信病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 09 | Month | 02 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 08 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 09 | Month | 02 | Day |
Last follow-up date
| 2015 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 09 | Month | 02 | Day |
Last modified on
| 2016 | Year | 12 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013590
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
