UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017260 |
|---|---|
| Receipt number | R000020002 |
| Scientific Title | A study of the effect of long-term anticholinergic administration -solifenacin succinate- |
| Date of disclosure of the study information | 2015/04/24 |
| Last modified on | 2015/04/23 22:36:54 |
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Basic information
Public title
A study of the effect of long-term anticholinergic administration
-solifenacin succinate-
Acronym
A study of the effect of long-term anticholinergic administration
Scientific Title
A study of the effect of long-term anticholinergic administration
-solifenacin succinate-
Scientific Title:Acronym
A study of the effect of long-term anticholinergic administration
Region
| Japan |
Condition
Condition
overactive bladder
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We evaluate the usefulness after 52 weeks treatment with solifenacin succinate in OAB patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We explore the factors that affect their usefulness in agent.
Key secondary outcomes
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
Solifenacin succinate 5 mg will be orally administered once a day after breakfast for 52 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)OAB patients (urgency score (OABSS) >= 2 and OABSS total score >= 3)
2)Residual urine volume <100ml
3)Patients from whom we have received written consent.
Key exclusion criteria
1)Patients who has contraindication of solifenacin succinate
2)Patients with prostate cancer
3)Patients with dutrusor underactivity
4)Patients with history of urethral stricture
5)Patients with history of radiation therapy
6,7)Patients with bladder cancer, urinary tract stones, symptomatic urinary tract infection, recurrent urinary tract infection and interstitial cystitis.
8)Patients with using self catheterization
9)Patients with history of resistance to anti-holinergic agents
10)Any other patients who are regarded as unsuitable for this study by the investigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Tanaka |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Renal and Genitourinary surgery
Zip code
Address
North 15, West 7, Kita-ku, Sapporo, 060-8638, Japan
TEL
011-706-5966
h-tanaka@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Tanaka |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Renal and Genitourinary surgery
Zip code
Address
North 15, West 7, Kita-ku, Sapporo, 060-8638, Japan
TEL
011-706-5966
Homepage URL
h-tanaka@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 04 | Month | 24 | 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
| 2008 | Year | 11 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 12 | Month | 07 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 04 | Month | 23 | Day |
Last modified on
| 2015 | Year | 04 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020002
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
