UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001878 |
|---|---|
| Receipt number | R000002264 |
| Scientific Title | Demographic survey in patients with overactive bladder and investigation on efficacy and safety of antimuscarinic agents. |
| Date of disclosure of the study information | 2009/04/16 |
| Last modified on | 2012/10/13 15:33:30 |
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Basic information
Public title
Demographic survey in patients with overactive bladder and investigation on efficacy and safety of antimuscarinic agents.
Acronym
TOPICS
(Tokyo OAB Patients Imidafenacin-Control Study)
Scientific Title
Demographic survey in patients with overactive bladder and investigation on efficacy and safety of antimuscarinic agents.
Scientific Title:Acronym
TOPICS
(Tokyo OAB Patients Imidafenacin-Control Study)
Region
| Japan |
Condition
Condition
Overactive bladder
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Demographics of patients with overactive bladder are analyzed on the relation with the metabolic syndrome/the lifestyle diseases.
The most recently-launched antimuscarinic agent, imidafenacin is investigated for efficacy and safety in overactive bladder treatment compared with existing antimuscarinic drugs.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
After 3 months, 6 months, 12 months of treatment, the efficacy ( Overactive Bladder Sympton Score (OABSS)) and the safety (Ministry of Health, Labour and Welfare science of long life synthesis research business "Interview sheet to the subjective symptom of the intraoral dryness. ") of antimuscarinic agents will be evaluated .
Key secondary outcomes
Core Lower Urinary Tract Symptom Score (CLSS), International Prostate Symptom Score (IPSS), Athens insomnia standard (AIS), prevalence and severity of side effect , time to dry mouth , Japanese version CAS, QT elongation, urinary retention, treatment discontinuation, SF-12, time to efficacy, and the treatment satisfaction rating will be evaluated in 3 months, 6 months, 12 months after the beginning of administration .
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
No need to know
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Imidafenacin 0.1 mg is orally administered to the patients with overactive bladder twice a day, after the breakfast and supper, for one year as possible, at least for three months.
Interventions/Control_2
Propiverine Hydrochloride 20 mg is orally administered to the patients with overactive bladder once a day after a meal for one year as possible, at least for three months.
Interventions/Control_3
Solifenacin Succinate 5 mg is orally administered to the patients with overactive bladder once a day for one year as possible, at least for three months.
Interventions/Control_4
Tolterodine Tartrate 4 mg is orally administered to the patients with overactive bladder once a day for one year as possible, at least for three months.
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with Q3 score of Overactive Bladder Symptom Score(OABSS) >=2 and the total score >=3 and agree with participation in this examination will be enrolled.
Key exclusion criteria
1) Prostate Specific Antigen (PSA) >=1.5 ng/ml.
2) stress urinary incontinence (CLSS:Q5 >=2 point).
3) bladder pain (CLSS:Q9 >=2 point).
4) voiding difficulty (CLSS:Q7 >=2 point).
5) a significant residual urine.(Significance is by physicians judged)
6) hematuria or pyuria.
7) positive urinary cytology.
8) contraindications to antimusucarinic agents.
a. urinary retention.
b. obstruction in pylorus, duodenum or intestinum and paralytic ileus.
c. decreased gastrointestinal motility.
d. closed-angle glaucoma.
e. myasthenia gravis.
f. serious heart failure.
g. serious hepatic dysfunction (Child-Pugh classification C).
h. hypersensitivity to the drug substance or other components of each products.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yukio Homma |
Organization
The University of Tokyo
Division name
Urology
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, JAPAN
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
The University of Tokyo
Division name
Urology
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo, JAPAN
TEL
Homepage URL
Sponsor or person
Institute
TOPICS society (Tokyo OAB Patients Imidafenacin-Control Study society)
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
| 2009 | Year | 04 | Month | 16 | 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 | 03 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 03 | 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
| 2009 | Year | 04 | Month | 13 | Day |
Last modified on
| 2012 | Year | 10 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002264
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