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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023716
Receipt No. 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

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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
Email 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
Email teraoka@kobepharma-u.ac.jp

Sponsor
Institute Kobe Pharmaceutical University
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027319

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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