UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011937 |
|---|---|
| Receipt number | R000013938 |
| Scientific Title | The evaluation of pharmacokinetic and pharmacodynamic properties of Propiverine Hydrochloride transdermal formulation |
| Date of disclosure of the study information | 2013/10/01 |
| Last modified on | 2014/10/01 10:01:57 |
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Basic information
Public title
The evaluation of pharmacokinetic and pharmacodynamic properties of Propiverine Hydrochloride transdermal formulation
Acronym
Pharmacokinetic and pharmacodynamic evaluation of Propiverine Hydrochloride transdermal formulation
Scientific Title
The evaluation of pharmacokinetic and pharmacodynamic properties of Propiverine Hydrochloride transdermal formulation
Scientific Title:Acronym
Pharmacokinetic and pharmacodynamic evaluation of Propiverine Hydrochloride transdermal formulation
Region
| Japan |
Condition
Condition
overactive bladder
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the pharmacokinetic and pharmacodynamic properties of newly depeloped propiverine hydrochloride transdermal formulation
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
pharmacokinetic parameters and sialoschesis effect of propiverine hydrochloride
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
administration of propiverine hydrochloride transdermal formulation
Interventions/Control_2
administration of propiverine hydrochloride tablet
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
| 60 | years-old | > |
Gender
Male
Key inclusion criteria
to be healthy
BMI:16<=, <28
Key exclusion criteria
having skin problems
history of allergy
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiromitsu Imai |
Organization
Oita University Hospital
Division name
Clinical Pharmacology Center
Zip code
Address
1-1 Idaigaoka, Hasama, Yufu-city, Oita, JAPAN
TEL
097-586-5952
imaih@oita-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiromitsu Imai |
Organization
Oita University Hospital
Division name
Clinical Pharmacology Center
Zip code
Address
1-1 Idaigaoka, Hasama, Yufu-city, Oita, JAPAN
TEL
097-586-5952
Homepage URL
imaih@oita-u.ac.jp
Sponsor or person
Institute
Dept of Clinical Pharmacology and Therapeutics, Oita University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
University of Shizuoka
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 10 | 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
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
| 2013 | Year | 05 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 10 | Month | 02 | Day |
Last follow-up date
| 2014 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 10 | Month | 01 | Day |
Last modified on
| 2014 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013938
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
