UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Influence of water content in skin and transepidermal water loss on residual drug amount in used Fentos tape
Title of the study (Brief title)	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	Reiko Teraoka
Organization	Kobe Pharmaceutical University
Division name	Department of Pharmaceutical Technology
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	Reiko Teraoka
Organization	Kobe Pharmaceutical University
Division name	Department of Pharmaceutical Technology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 07 Month 06 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000027319