UMIN-CTR Clinical Trial

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

osteoarthritis

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -participants are blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Tokyo Medical and Dental University

Institute

Department

Personal name

Organization

Taisho Toyama Pharmaceutical Co., Ltd
Teijin Pharma Limited

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

11

Month

10

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2016

Year

11

Month

10

Day

Last modified on

2018

Year

11

Month

09

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028518