UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005951 |
|---|---|
| Receipt number | R000007034 |
| Scientific Title | Adhesive power and skin-related adverse event of two types of daily fentanyl transdermal patches |
| Date of disclosure of the study information | 2011/07/08 |
| Last modified on | 2012/07/09 19:22:36 |
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Basic information
Public title
Adhesive power and skin-related adverse event of two types of daily fentanyl transdermal patches
Acronym
Adhesive power and skin-related adverse event of two types of daily fentanyl transdermal patches
Scientific Title
Adhesive power and skin-related adverse event of two types of daily fentanyl transdermal patches
Scientific Title:Acronym
Adhesive power and skin-related adverse event of two types of daily fentanyl transdermal patches
Region
| Japan |
Condition
Condition
Malignancy
Classification by specialty
| Not applicable |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate adhesive power and skin-related adverse event of two types of daily fentanyl transdermal patch preparation examples on the skin of cancer patients
Basic objectives2
Others
Basic objectives -Others
Adhesive power of two types of daily fentanyl transdermal patch preparation examples
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Degree of detachment of fentanyl transdermal patch preparation examples
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is 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
Put two types of fentanyl transdermal patch preparation examples
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Malignancy
2) Need to be hospitalized at least 5 days
3) Without dementia
4) Aged 20 years old or above
5) Written informed consent
Key exclusion criteria
1) Severe skin disorder or wound on the upper arm or chest or abdomen or thigh
2) Having been registered before
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Saito |
Organization
Aichi Cancer Center Aichi Hospital
Division name
Department of Respiratory Medicine
Zip code
Address
18 Kuriyado Kake-machi, Okazaki Aichi 444-0011, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kosuke Takahashi |
Organization
Aichi Cancer Center Aichi Hospital
Division name
Department of Respiratory Medicine
Zip code
Address
TEL
0564-21-6251
Homepage URL
ktakahashi@acc-aichi.com
Sponsor or person
Institute
Aichi Cancer Center Aichi 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
愛知県がんセンター愛知病院
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 07 | Month | 08 | 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
Completed
Date of protocol fixation
| 2011 | Year | 07 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 07 | Month | 08 | Day |
Last modified on
| 2012 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007034
