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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001878
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute TOPICS society (Tokyo OAB Patients Imidafenacin-Control Study society)
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002264

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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