UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The efficacy of intra-articular hyaluronic acid injections on knee osteoarthritis patients
Title of the study (Brief title)	comparative trial of HA of three kinds (CHAT study)
Region	Japan

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

Objectives
Narrative objectives1	The effect of intra-articular treatment of knee osteoarthritis with hyaluronic acid in the knee joint is not based on randomized controlled trials.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	WOMAC pain, function score
Key secondary outcomes	1. Visual Analog Scale 2. EQ5D 3. KOACAD parameter on plain knee radiograph

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	4
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Synvisc: Active Comparator
Interventions/Control_2	Suvenyl: Active Comparator
Interventions/Control_3	Artz: Active Comparator
Interventions/Control_4	Topical NSAIDs: Active Comparator
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	40 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Males and females 40 to 80 years of age. 2. The ACR Criteria for osteoarthritis of the knee. 3. Radiographic evidence of OA, Kellgren and Lawrence grade 1 to 3 on prior X-rays at screening. Only the tibio-femoral joint will be evaluated. 4. Chronic pain for at least 1 month prior to study entry (WOMAC pain score)
Key exclusion criteria	1. An intra-articu1ar knee injection (with any corticosteroid, hyaluronic acid preparation or other) within the previous three months. 2. A history of crystalline arthropathy or inflammatory arthritis, neutopathic arthropathy. 3. A current other problem in the affected extremity. 4. A history of clinically significant trauma or surgery. 5. Allergy or hypersensitivity to any of the study medications. 6. Joint effusion. 7. Non comp1iance to the study procedures and or non completion of the study according to investigator's judgment.
Target sample size	600

Research contact person
Name of lead principal investigator	Hiroyuki Oka
Organization	Faculty of Medicine, the University of Tokyo
Division name	22nd Century Medical Center
Address	Hongo 7-3-1, Bunkyo, Tokyo
TEL	03-5800-9545
Email	okah-tky@umin.ac.jp

Public contact
Name of contact person	Hiroyuki Oka
Organization	Faculty of Medicine, University of Tokyo
Division name	22nd Century Medical Center
Address	Hongo 7-3-1, Bunkyo, Tokyo
TEL	03-5800-9178
Homepage URL
Email	okah-tky@umin.ac.jp

Sponsor
Institute	University of Tokyo
Institute
Department

Funding Source
Organization	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)

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	2012 Year 10 Month 06 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 10 Month 06 Day
Anticipated trial start date	2012 Year 11 Month 30 Day
Last follow-up date	2015 Year 12 Month 23 Day
Date of closure to data entry	2016 Year 06 Month 01 Day
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 10 Month 06 Day
Last modified on	2017 Year 03 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010439