UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041567 |
|---|---|
| Receipt number | R000047437 |
| Scientific Title | Micro determination of non-steroidal anti - inflammatory patches in dried blood spots using high performance liquid chromatography / tandem mass spectrometry |
| Date of disclosure of the study information | 2020/11/01 |
| Last modified on | 2020/08/26 21:19:32 |
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Basic information
Public title
Micro determination of non-steroidal anti - inflammatory patches in dried blood spots using high performance liquid chromatography / tandem mass spectrometry
Acronym
Micro determination of non-steroidal anti - inflammatory patches in dried blood spots using high performance liquid chromatography / tandem mass spectrometry
Scientific Title
Micro determination of non-steroidal anti - inflammatory patches in dried blood spots using high performance liquid chromatography / tandem mass spectrometry
Scientific Title:Acronym
Micro determination of non-steroidal anti - inflammatory patches in dried blood spots using high performance liquid chromatography / tandem mass spectrometry
Region
| Japan |
Condition
Condition
Joint pain, muscle pain, osteoarthritis, rheumatoid arthritis
Classification by specialty
| Medicine in general | Surgery in general | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To construction of blood concentration measurement system for patch NSAIDs ( Non-Steroidal Anti-Inflammatory Drugs ) by DBS ( Dry blood spot)
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
blood concentration for patch NSAIDs
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
Patients using patches NSAIDs
Key exclusion criteria
No exclusion criteria
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Suzuki |
| Middle name | |
| Last name | Akio |
Organization
Gifu University Hospital
Division name
Department of Pharmacy
Zip code
501-1194
Address
1-1, Yanagido,Gifu-shi,Gifu
TEL
058-230-6000
akio@gifu-u.ac.jp
Public contact
Name of contact person
| 1st name | Yamazaki |
| Middle name | |
| Last name | Mizuki |
Organization
Gifu University Hospital
Division name
Department of Pharmacy
Zip code
501-1194
Address
1-1, Yanagido,Gifu-shi,Gifu
TEL
058-230-6000
Homepage URL
y_mizuki@gifu-u.ac.jp
Sponsor or person
Institute
Gifu University
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
Gifu Pharmaceutical University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The ethics committee of the Gifu University Graduate School of Medicine
Address
1-1 Yanagido, Gifu
Tel
058-230-6059
rinri@gifu-u.ac.jp
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
| 2020 | Year | 11 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2020 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 11 | Month | 10 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observation of blood level of patch NSAIDs by DBS method and conventional method
Management information
Registered date
| 2020 | Year | 08 | Month | 26 | Day |
Last modified on
| 2020 | Year | 08 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047437
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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