UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023716 |
|---|---|
| Receipt number | R000027319 |
| Scientific Title | Influence of water content in skin and transepidermal water loss on residual drug amount in used Fentos tape |
| Date of disclosure of the study information | 2016/08/22 |
| Last modified on | 2019/02/18 14:28:24 |
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Basic information
Public title
Influence of water content in skin and transepidermal water loss on residual drug amount in used Fentos tape
Acronym
Influence of water content in skin and transepidermal water loss on residual drug amount in used Fentos tape
Scientific Title
Influence of water content in skin and transepidermal water loss on residual drug amount in used Fentos tape
Scientific Title:Acronym
Influence of water content in skin and transepidermal water loss on residual drug amount in used Fentos tape
Region
| Japan |
Condition
Condition
cancer pain
Classification by specialty
| Not applicable |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
There were significant differences in the residual fentanyl citrate of used fentos tapes among patients.
The objective of this study was to elucidate whether the variation of fentanyl residual caused by the skin condition of patients.
Basic objectives2
Others
Basic objectives -Others
nothing
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
transepidermal water loss
water content in corner
residual of fentanyl citrate in used patches
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients who are required for cancer pain control and are put on fentos tape
Key exclusion criteria
nothing
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Reiko Teraoka |
Organization
Kobe Pharmaceutical University
Division name
Department of Pharmaceutical Technology
Zip code
Address
4-19-1, Motoyamakita-machi, Higashinada-ku, Kobe, 658-8558, Japan
TEL
078-441-7531
teraoka@kobepharma-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Reiko Teraoka |
Organization
Kobe Pharmaceutical University
Division name
Department of Pharmaceutical Technology
Zip code
Address
4-19-1, Motoyamakita-machi, Higashinada-ku, Kobe, 658-8558, Japan
TEL
078-441-7531
Homepage URL
teraoka@kobepharma-u.ac.jp
Sponsor or person
Institute
Kobe Pharmaceutical University
Institute
Department
Personal name
Funding Source
Organization
Kobe Pharmaceutical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Ashiya Municipal Hospital
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
市立芦屋病院、神戸薬科大学製剤学研究室
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 08 | Month | 22 | 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
| 2016 | Year | 07 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 08 | Month | 22 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
nothing
Management information
Registered date
| 2016 | Year | 08 | Month | 22 | Day |
Last modified on
| 2019 | Year | 02 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027319
