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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006420
Receipt No. R000007618
Scientific Title Efficacy and safety of anticholinergic agents applied for day-time or night-time
Date of disclosure of the study information 2011/11/01
Last modified on 2016/10/02

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Basic information
Public title Efficacy and safety of anticholinergic agents applied for day-time or night-time
Acronym Efficacy and safety of anticholinergic agents applied for day-time or night-time
Scientific Title Efficacy and safety of anticholinergic agents applied for day-time or night-time
Scientific Title:Acronym Efficacy and safety of anticholinergic agents applied for day-time or night-time
Region
Japan

Condition
Condition Overactive bladder
Classification by specialty
Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of study is to examine efficacy and safety of Detrusitol, an anticholinergic agent, applied for day-time or night-time.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The presence of dry mouth induced by Detrusitol, an anticholinergic agent, applied for day-time or night-time will be investigated.
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 Detrusitor
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
100 years-old >
Gender Male and Female
Key inclusion criteria Patients with overactive bladder
Key exclusion criteria 1.Urinary retention has occured through the latest 1 year.
2.Post voied residual urine volume is more than 100ml.
3.The treatment has been already done.
4.Patients have sleep disturbance.
5.Patients have irregular life styles.
6.Patients have inhibited diseases for the use of anticholinergic agents.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akira Furuta
Organization Jikei University School of Medicine
Division name Urology
Zip code
Address 3-25-8 Nishi-shinbashi, Minato-ku, Tokyo
TEL 03-3433-1111
Email a-furuta@jikei.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akira Furuta
Organization Jikei University School of Medicine
Division name Urology
Zip code
Address 3-25-8 Nishi-shinbashi, Minato-ku, Tokyo
TEL 03-3433-1111
Homepage URL
Email a-furuta@jikei.ac.jp

Sponsor
Institute Jikei University School of Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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 東京慈恵会医科大学附属病院泌尿器科、第三病院泌尿器科、柏病院泌尿器科、青戸病院泌尿器科

Other administrative information
Date of disclosure of the study information
2011 Year 11 Month 01 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
There were no significant differences between the nighttime and daytime treatment of tolterodine in terms of the adverse events such as thirsty in OAB patients. However, the limitation of this study is a few registrated number of patient (n=10), so
that further stufy will be needed to clalify this point.
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
2011 Year 10 Month 03 Day
Date of IRB
Anticipated trial start date
2011 Year 11 Month 01 Day
Last follow-up date
2012 Year 10 Month 30 Day
Date of closure to data entry
2012 Year 12 Month 31 Day
Date trial data considered complete
2012 Year 12 Month 31 Day
Date analysis concluded
2013 Year 05 Month 31 Day

Other
Other related information None

Management information
Registered date
2011 Year 09 Month 28 Day
Last modified on
2016 Year 10 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007618

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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