UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003033 |
|---|---|
| Receipt number | R000003676 |
| Scientific Title | Global Assessment Study of Anti-cholinergics on Efficacy and Tolerability for Patients with OAB |
| Date of disclosure of the study information | 2010/04/14 |
| Last modified on | 2011/01/14 15:40:35 |
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Basic information
Public title
Global Assessment Study of Anti-cholinergics on Efficacy and Tolerability for Patients with OAB
Acronym
GAP Study
Scientific Title
Global Assessment Study of Anti-cholinergics on Efficacy and Tolerability for Patients with OAB
Scientific Title:Acronym
GAP Study
Region
| Japan |
Condition
Condition
Overactive bladder
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
For the Overactive bladder patients, the effectiveness of imidafenacin and solifenacin is evaluated. And, safety of the dry mouth and constipation is evaluated with an interview sheet.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
After 4 weeks, 8 weeks, 12 weeks of treatment, the efficacy ( Overactive Bladder Symptom Score (OABSS)) will be evaluated.
Key secondary outcomes
After 4 weeks, 8 weeks, 12 weeks of treatment, Dry Mouth symptom and Constipation symptom will be evaluated.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Imidafenacin 0.1mg is orally administered to the patients with overactive bladder twice a day, after the breakfast and supper.
Interventions/Control_2
Solifenacin Succinate 5mg is orally administered to the patients with overactive bladder once a day.
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) Patients with Q3 score of Overactive Bladder Symptom Score (OABSS) >=2 and the total score >=3.
(2) 20 years old or more outpatient
(3) Written consent with participation in this examination will be enrolled.
Key exclusion criteria
(1) Genuine stress incontinence.
(2) Prostate cancer, bladder cancer, urinary tract stones, symptomatic urinary tract infection, recurrent urinary tract infection and interstitial cystitis.
(3) Indwelling or intermittent urethral catheterization.
(4) Polyuria.
(5) Lower urinary tract symptom is unstable.
(6) Serious heart failure, serious liver failure and serious kidney failure.
(7) Contraindications to antimusucarinic agents.
(8) Sjogren's syndrome or hyposalivation by RT.
(9) Treatment with banned medicine within 2 weeks before the run-in period.
(10) Electric stimulation therapy or bladder training within 3 months before the run-in period.
(11) Genitourinary surgery within 6 months before the run-in period.
(12) Any other cases who are regarded as inadequate for study enrollment by the investigator.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hisae Nishii |
Organization
The University of Occupational and Environmental Health
Division name
Urology
Zip code
Address
1-1 Iseigaoka, Yahatanishi-ku kitakyusyu-shi, Fukuoka, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
The University of Occupational and Environmental Health
Division name
Urology
Zip code
Address
1-1 Iseigaoka, Yahatanishi-ku kitakyusyu-shi, Fukuoka, Japan
TEL
Homepage URL
Sponsor or person
Institute
GAP Study Group
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
None
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
| 2010 | Year | 04 | Month | 14 | 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
| 2009 | Year | 08 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 01 | Month | 14 | Day |
Last modified on
| 2011 | Year | 01 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003676
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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