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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024789
Receipt No. R000028518
Scientific Title The examination of concentration of drug in tissues from the knee osteoarthritis patients who use the Esflurbiprofen tape or Flurbiprofen
Date of disclosure of the study information 2016/11/10
Last modified on 2018/11/09

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Basic information
Public title The examination of concentration of drug in tissues from the knee osteoarthritis patients who use the Esflurbiprofen tape or Flurbiprofen
Acronym The examination of concentration of drug in tissues from the knee osteoarthritis patients who use the Esflurbiprofen tape or Flurbiprofen
Scientific Title The examination of concentration of drug in tissues from the knee osteoarthritis patients who use the Esflurbiprofen tape or Flurbiprofen
Scientific Title:Acronym The examination of concentration of drug in tissues from the knee osteoarthritis patients who use the Esflurbiprofen tape or Flurbiprofen
Region
Japan

Condition
Condition osteoarthritis
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We make a study of the potential tissues transfer by concentration measurement of Esfl urbiprofen and Flurbiprofen in the knee osteoarthritis patients.
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes We evaluate the concentration measurement of Esfl urbiprofen and Flurbiprofen, the blood concentration of PGE2, the change of NRS at 7 days after starting the medication.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 9
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 The patients use Esflurbiprofen tape a once-a-day the last seven days before total knee arthroplasty.
Interventions/Control_2 The patients use Esflurbiprofen tape a once-a-day the last seven days before total knee arthroplasty.
Interventions/Control_3 The patients use Esflurbiprofen tape a once-a-day the last seven days before total knee arthroplasty.
Interventions/Control_4 The patients use Esflurbiprofen tape a once-a-day the last seven days before total knee arthroplasty.
Interventions/Control_5 The patients take orally Flurbiprofen three times a day the last seven days before total knee arthroplasty.
Interventions/Control_6 The patients take orally Flurbiprofen three times a day the last seven days before total knee arthroplasty.
Interventions/Control_7 The patients take orally Flurbiprofen three times a day the last seven days before total knee arthroplasty.
Interventions/Control_8 The patients take orally Flurbiprofen three times a day the last seven days before total knee arthroplasty.
Interventions/Control_9 only obsevation
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria the patients who are performed lateral or bilateral total knee arthroplasty.
Key exclusion criteria the patients who have history of trauma or a complication
the patients who treated with NSAIDs, hyaluronic acid, steroid.
Target sample size 14

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideyuki Koga
Organization Tokyo Medical and Dental University
Division name Department of joint surgery and sport medicine
Zip code
Address 1-5-45 Yushima Bunkyouku Tokyo, JAPAN
TEL 03-5803-4675
Email koga.orj@tmd.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hideyuki Koga
Organization Tokyo Medical and Dental University
Division name Department of joint surgery and sport medicine
Zip code
Address 1-5-45 Yushima Bunkyouku Tokyo, JAPAN
TEL 03-5803-4675
Homepage URL
Email koga.orj@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization Taisho Toyama Pharmaceutical Co., Ltd
Teijin Pharma Limited
Organization
Division
Category of Funding Organization Profit organization
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

Other administrative information
Date of disclosure of the study information
2016 Year 11 Month 10 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
2016 Year 11 Month 08 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 05 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 11 Month 10 Day
Last modified on
2018 Year 11 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028518

Research Plan
Registered date File name
2018/11/09 研究計画書 ロコアテープ臨床研究 修正最新版.docx

Research case data specifications
Registered date File name
2018/11/09 コピーロコア PGE.xlsx

Research case data
Registered date File name
2018/11/09 コピー検体測定結果_ フルルビプロフェン1.xlsx


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