UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018175 |
|---|---|
| Receipt number | R000021019 |
| Scientific Title | Response to intravenous fentanyl infusion predicts subsequent response to transdermal fentanyl |
| Date of disclosure of the study information | 2015/07/03 |
| Last modified on | 2015/07/03 12:23:45 |
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Basic information
Public title
Response to intravenous fentanyl infusion predicts subsequent response to transdermal fentanyl
Acronym
Intravenous fentanyl before transdermal fentanyl
Scientific Title
Response to intravenous fentanyl infusion predicts subsequent response to transdermal fentanyl
Scientific Title:Acronym
Intravenous fentanyl before transdermal fentanyl
Region
| Japan |
Condition
Condition
chronic pain
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine that the response to intravenous fentanyl infusion can predict the response to transdermal fentanyl
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
numerical rating scale
clinical global impression improvement scale
satisfaction scale
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
interview
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
age from 20 to 85
body weight from 30 to 100kg
pain persisting for more than 3 months
more than 4 of NRS
Key exclusion criteria
psychiatric disease
serious chronic disease such as cardiac failure, pulmonary emphysema, and interstitial hepatitis
skin problems that might affect transdermal delivery
life-limiting conditions
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akifumi Kanai |
Organization
Kitasato University School of Medicine
Division name
Research and Developmemt Center for New Medical Frontiers
Zip code
Address
1-15-1 Kitasato, Minami-ku, Sagamihara 252-0374 Japan
TEL
042-778-8111
kanaiakifumi@aol.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Norihito Hayashi |
Organization
Kitasato University School of Medicine
Division name
Anesthesiology
Zip code
Address
1-15-1 Kitasato, Minami-ku, Sagamihara 252-0374 Japan
TEL
042-778-8111
Homepage URL
mininoriton@ybb.ne.jp
Sponsor or person
Institute
Department of Anesthesiology, Kitasato University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kitasato University Hospital
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
| 2015 | Year | 07 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2012 | Year | 11 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 11 | Month | 09 | 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
| 2015 | Year | 07 | Month | 03 | Day |
Last modified on
| 2015 | Year | 07 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021019
