UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007149 |
|---|---|
| Receipt number | 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 23:17:27 |
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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
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
kyohei@u-fukui.ac.jp
Public contact
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
kyohei@u-fukui.ac.jp
Sponsor or person
Institute
Department of Pharmacy, University of Fukui hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008418
