UMIN-CTR Clinical Trial

Basic information
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
Condition	Knee Osteoarthritis
Classification by specialty	Orthopedics
Classification by malignancy	Others
Genomic information	NO

Objectives
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

Assessment
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.

Base
Study type	Interventional

Study design
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

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute	The Japanese Society for Musculoskeletal Rehabilitation
Institute
Department

Funding Source
Organization	External Pharmaceutical Association
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Japanese Clinical Orthopaedic Association
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	2005 Year 11 Month 15 Day

Related information
URL releasing protocol
Publication of results	Published

Result
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

Progress
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
Other related information

Management information
Registered date	2005 Year 11 Month 14 Day
Last modified on	2017 Year 04 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000360

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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