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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000023538
Receipt No. 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

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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
Email 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
Email tanaka.akihiro.mj@ehime-u.ac.jp

Sponsor
Institute Ehime university hospital division of pharmacy
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027109

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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