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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041567
Receipt No. 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

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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
Email 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
Email y_mizuki@gifu-u.ac.jp

Sponsor
Institute Gifu University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047437

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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