UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013063 |
|---|---|
| Receipt number | R000015239 |
| Scientific Title | Therapeutic effect of the drug of Parkinson`s disease on voiding dysfunction |
| Date of disclosure of the study information | 2014/02/07 |
| Last modified on | 2015/11/06 19:04:13 |
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Basic information
Public title
Therapeutic effect of the drug of Parkinson`s disease on voiding dysfunction
Acronym
Therapeutic effect of the drug of Parkinson`s disease on voiding dysfunction
Scientific Title
Therapeutic effect of the drug of Parkinson`s disease on voiding dysfunction
Scientific Title:Acronym
Therapeutic effect of the drug of Parkinson`s disease on voiding dysfunction
Region
| Japan |
Condition
Condition
patients with voiding dysfunction such as benign prostatic hyperplasia
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
the efficacy of the drug of Parkinson`s disease on voiding dysfunction
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
voiding efficacy (Qmax)
Key secondary outcomes
urinary frequency
questionaires for urinary symptom
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
observation period: 4week
the drug of Parkinson`s disease is administered for 12 weeks
The outcomes is evaluated every 4 weeks
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male
Key inclusion criteria
# international prostate symptom score (IPSS): >8
# QOL score: >4
# voided volume >100ml, Qmax: <15ml
# residual volume: <100ml
# eligible for coming to the outpatient clinic
# stable condition
Key exclusion criteria
# neurogenic bladder, bladder neck contracture, urethral stricture, urinary tract infection or other complication
# clear intermittent self catheterization
# allergic to the drug
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Teruyuki Ogawa |
Organization
Shinshu University School of Medicine
Division name
Department of urology
Zip code
Address
3-1-1 Asahi Matsumoto Nagano, Japan
TEL
0263-37-2661
ogawat@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Teruyuki Ogawa |
Organization
Shinshu University School of Medicine
Division name
Department of urology
Zip code
Address
3-1-1 Asahi Matsumoto Nagano, Japan
TEL
0263-37-2661
Homepage URL
ogawat@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of drug discovery science, Shinshu University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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
| 2014 | Year | 02 | Month | 07 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 02 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 02 | Month | 07 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 02 | Month | 03 | Day |
Last modified on
| 2015 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015239
