UMIN-CTR Clinical Trial

Public title

Effect of non-steroidal anti-inflammatory drugs external patch for Knee Osteoarthritis; An Open label Randomized Controlled Trial.

Acronym

Effect of NSAID external patch for Knee Osteoarthritis

Scientific Title

Effect of non-steroidal anti-inflammatory drugs external patch for Knee Osteoarthritis; An Open label Randomized Controlled Trial.

Scientific Title:Acronym

Effect of NSAID external patch for Knee Osteoarthritis

Region

Japan

Condition

Knee Osteoarthritis

Classification by specialty

Orthopedics

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To examine the effect of non-steroidal anti-inflammatory drugs (NSAIDs) external patch for knee osteoarthritis.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase III

Primary outcomes

Functional assessment including ADL: JKOM

Assessment of utility and safety.

Key secondary outcomes

Assessment of pain: VAS.

Assessment of adverse event in the trial period.

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Blocking

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Patch group: external patch
NSAIDs external patch were used on the tender spot around the knee joint 2 times (at morning, after bath or at night) per day. The external patch was kept at room temperature. The patients were able to stop their drugs when they no longer required treatment. NSAIDs were limited only one of the following three to prescribe; flurbiprofen, indometacin, and ketoprofen.

Interventions/Control_2

Oral agent group: Oral NSAIDs

NSAIDs were limited only one of the following three to prescribe. These were the top three used in Japan at the present; loxoprofen sodium, diclofenac sodium, and zaltoprofen. They were also required to record exactly how many they had been taking medicine in a note.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

50

years-old

<=

Age-upper limit

80

years-old

>

Gender

Male and Female

Key inclusion criteria

The patient satisfying the following conditions (1)-(6) is included.
(1) Outpatients with knee pain, age 50-80 years old. Both men and women are able to enter the trial.
(2) New patients for medical institution concerned, who receiving no treatment for their knees within 1 month before.
(3) Patients with the following knee symptoms in the more symptomatic side.
Morning stiffness less than 30 minutes,
Joint crepitus,
Tenderness at the joint space,
and palpable osteophytes
(4) As comobidity, hypertension, diabetes, and hyperlipidemia under medication are allowed to enter the trial.
(5) Patient who agreed to the following examinations.
[X-rays]: the anteroposterior view of both knee joints in a standing position were taken and used to confirm the diagnosis.
[Laboratory tests]: blood cell count (red blood cell, white blood cell, hemoglobin, hematocrit), biochemical examination (AST, ALT, ALP, BUN, creatinin, total cholesterol, triglyceride, uric acid), and routine urinalysis.
(6) Patient who understand aim and contents the trial and cooperate with filling the questionnaire.

Key exclusion criteria

(1) Patients who had treatment for their knee at other hospital or clinic, i.e., who received therapeutic exercise, intraarticular injection, or NSAIDs within 4 weeks before the day of agreement to enter the trial.
(2) Patients who had done or planned operation against the knee within 6 months before or after the day of agreement to enter the trial.
(3) Patients who require intraarticular injection.
(4) Patients who require aspiration of joint fluid.
(5) Patients who have diseases requiring regular or intermittent use of steroid or non-steroidal anti-inflammatory drugs.
(6) Patients who have articular cartilage injury or history of damage due to obvious trauma or septic arthritis.
(7) Patients who were diagnosed as rheumatoid arthritis, gout, pseudogout, or collagen diseases.
(8) Patients who had some difficulty to fill up their treatment diary.
(9) Patients with cardiac dysfunction.
(10) Patients with liver dysfunction.
(11) Patients with renal dysfunction.
(12) Patients with peptic ulcer.
(13)Patients who had a history of bronchial asthma (Aspirin asthma, etc).
(14) Patients who had a history of Anaphylaxis for NSAIDs.

Target sample size

300

Name of lead principal investigator

1st name
Middle name
Last name	Tsutomu Iwaya

Organization

Chief Director, The Japanese Society for Musculoskeletal Rehabilitation

Division name

The Japanese Society for Musculoskeletal Rehabilitation, c/o Department of Orthopaedic Surgery, Jichi Medical School

Zip code

Address

Yakusiji 3311-1, Minami-Kawachimachi, Tochigi

TEL

0285-58-7374

Email

Name of contact person

1st name
Middle name
Last name	Tsutomu Iwaya

Organization

National Rehabilitation Center for Persons with Disabilities

Division name

Director,Training Center

Zip code

Address

Namiki 4-1, Tokorozawa, Saitama

TEL

04-2995-3100(2010)

Homepage URL

Email

iwaya@rehab.go.jp

Institute

The Japanese Society for Musculoskeletal Rehabilitation

Institute

Department

Personal name

Organization

External Pharmaceutical Association

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

Co-sponsor

Japanese Clinical Orthopaedic Association

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

2005

Year

11

Month

15

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

Number of participants that the trial has enrolled

Results

Local application of a plaster with non- steroidal anti-inflammatory drugs (NSAIDs) leads to the same level of improvement for knee osteoarthritis in Japanese as oral NSAIDs.

Doi T, Akai M, Fujino K, et al.: Effect of non-steroidal anti-inflammatory drug plasters for knee osteoarthritis in Japanese: A randomized controlled trial. Modern Rheumatology 20(1): 24-33, 2010

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

2004

Year

10

Month

22

Day

Date of IRB

Anticipated trial start date

2005

Year

01

Month

01

Day

Last follow-up date

2006

Year

01

Month

01

Day

Date of closure to data entry

2006

Year

04

Month

01

Day

Date trial data considered complete

2006

Year

04

Month

01

Day

Date analysis concluded

2006

Year

05

Month

01

Day

Other related information

Registered date

2005

Year

11

Month

14

Day

Last modified on

2017

Year

04

Month

24

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000360