UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023538 |
|---|---|
| Receipt number | R000027109 |
| Scientific Title | A Questionnaire Usability Survey of Generic Fentanyl Tape for 3 Days |
| Date of disclosure of the study information | 2016/08/16 |
| Last modified on | 2016/09/30 08:54:01 |
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Basic information
Public title
A Questionnaire Usability Survey of Generic Fentanyl Tape for 3 Days
Acronym
A Questionnaire Usability Survey of Generic Fentanyl Tape for 3 Days
Scientific Title
A Questionnaire Usability Survey of Generic Fentanyl Tape for 3 Days
Scientific Title:Acronym
A Questionnaire Usability Survey of Generic Fentanyl Tape for 3 Days
Region
| Japan |
Condition
Condition
healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In consideration of switching to fentanyl tape for 3 days of generic products, we must choose the tape that has not peeling, itching and discomfort of the application site and has good openability. In this study, we investigate the feeling of use and openability by questionnaire about bland-name and generic products that contains no agent component.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Openability, operability, Tackiness, Deciduous, Peeling property, skin feeling
Key secondary outcomes
Patients recommended degree
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
A sample of fentanyl tape application on abdominal, 3 days
Interventions/Control_2
A sample of fentanyl tape application on abdominal, 3 days
Interventions/Control_3
A sample of fentanyl tape application on abdominal, 3 days
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Division of pharmacy staff in our hospital without this research member
Key exclusion criteria
Individuals who have had an allergy caused by tape or poultice
Individuals with a skin disease in application site
Individuals who are already using the other tape or poultice in the adaptive sites
Women who are or may be pregnant and nursing women
Individuals who have severe systemic illness with an expected life
Individuals who have severe liver dysfunction or severe renal dysfunction
Individuals and these families who have a conflict of interest
Individuals who are diagnosed as inappropriate for the trial
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroaki Araki |
Organization
Ehime university hospital
Division name
Division of pharmacy
Zip code
Address
Shitsukawa 454, Toon, Ehime, Japan
TEL
089-960-5730
haraki@m.ehime-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akihiro Tanaka |
Organization
Ehime university hospital
Division name
Division of pharmacy
Zip code
Address
Shitsukawa 454, Toon, Ehime, Japan
TEL
089-960-5731
Homepage URL
tanaka.akihiro.mj@ehime-u.ac.jp
Sponsor or person
Institute
Ehime university hospital division of pharmacy
Institute
Department
Personal name
Funding Source
Organization
Ehime university hospital division of pharmacy
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
愛媛大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 08 | Month | 16 | 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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 06 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 08 | Month | 16 | 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
| 2016 | Year | 08 | Month | 08 | Day |
Last modified on
| 2016 | Year | 09 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027109
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
