UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006420 |
|---|---|
| Receipt number | 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 07:51:08 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
a-furuta@jikei.ac.jp
Sponsor or person
Institute
Jikei University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007618
