UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013505 |
|---|---|
| Receipt number | R000015722 |
| Scientific Title | Study of evaluating the efficacy of microneedle may reduce the injection pain of the melanoma patinet receiving interferon-beta as an adjuvant therapy |
| Date of disclosure of the study information | 2014/04/01 |
| Last modified on | 2015/09/25 09:56:38 |
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Basic information
Public title
Study of evaluating the efficacy of microneedle may reduce the injection pain of the melanoma patinet receiving interferon-beta as an adjuvant therapy
Acronym
interferon and microneedle
Scientific Title
Study of evaluating the efficacy of microneedle may reduce the injection pain of the melanoma patinet receiving interferon-beta as an adjuvant therapy
Scientific Title:Acronym
interferon and microneedle
Region
| Japan |
Condition
Condition
Melanoma patient receiving intradermal injection of interferon-beta as adjuvant therapy
Classification by specialty
| Dermatology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the pain reduction efficacy of using microneedle when injecting interferon-beta intradermally
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Visual analogue scale
Key secondary outcomes
Base
Study type
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Using 34G microneedle
Interventions/Control_2
29G insulin injector
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patient using interferon-beta as an adjuvant therapy of malignant melanoma
Key exclusion criteria
none
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuhiro Fujisawa |
Organization
University of Tsukuba
Division name
Dermatology
Zip code
Address
1-1-1Tennodai, Tsukbua city
TEL
0298533128
fujisan@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuhiro Fujisawa |
Organization
University of Tsukuba
Division name
Dermatology
Zip code
Address
1-1-1Tennodai, Tsukbua city
TEL
0298533128
Homepage URL
fujisan@md.tsukuba.ac.jp
Sponsor or person
Institute
Yasuhiro Fujisawa
Institute
Department
Personal name
Funding Source
Organization
University of Tsukuba
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
| 2014 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
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
| 2014 | Year | 03 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2014 | Year | 12 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 03 | Month | 25 | Day |
Last modified on
| 2015 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015722
