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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000007149
Receipt No. R000008418
Scientific Title Pharmacokinetic study of transdermal fentanyl among of two types of one-day patches.
Date of disclosure of the study information 2012/01/26
Last modified on 2015/02/13

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Basic information
Public title Pharmacokinetic study of transdermal fentanyl among of two types of one-day patches.
Acronym Pharmacokinetic study of transdermal fentanyl among of two types of one-day patches.
Scientific Title Pharmacokinetic study of transdermal fentanyl among of two types of one-day patches.
Scientific Title:Acronym Pharmacokinetic study of transdermal fentanyl among of two types of one-day patches.
Region
Japan

Condition
Condition Cancer pain
Classification by specialty
Not applicable
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 This study is designed to evaluate the pharmacokinetics of transdermal fentanyl among two types of one-day patches, Fentos Tape and OneDuro Patch.
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Blood concentration of fentanyl
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Blood concentration is measured after randomizing patients to Fentos Tape or OneDuro Patch.
Interventions/Control_2 Blood concentration is measured after randomizing patients to OneDuro Patch or Fentos Tape.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Patient who treated with transdermal fentanyl of one-day patches.
2. Patient who are capable of providing written informed consent.
Key exclusion criteria Patients seems inadequate for this study by investigators
Target sample size 20

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Kyohei Watanabe
Organization University of Fukui hospital
Division name Department of Pharmacy
Zip code
Address 23-3, Matsuokashimoaizuki, eiheiji-cho, Yoshida-gun, Fukui 910-1193 JAPAN
TEL 0776-61-3111
Email kyohei@u-fukui.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Kyohei Watanabe
Organization University of Fukui hospital
Division name Department of Pharmacy
Zip code
Address 23-3, Matsuokashimoaizuki, eiheiji-cho, Yoshida-gun, Fukui 910-1193 JAPAN
TEL 0776-61-3111
Homepage URL
Email kyohei@u-fukui.ac.jp

Sponsor
Institute Department of Pharmacy, University of Fukui hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information
2012 Year 01 Month 26 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
2011 Year 07 Month 14 Day
Date of IRB
Anticipated trial start date
2011 Year 09 Month 01 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
2012 Year 01 Month 26 Day
Last modified on
2015 Year 02 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008418

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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