UMIN-CTR Clinical Trial

Basic information
Public title	Comparison of efficacy of two high-molecular-weight hyaluronic acid products in patients with knee osteoarthritis
Acronym	Comparative study of hyaluronic acid products in patients with knee osteoarthritis
Scientific Title	Comparison of efficacy of two high-molecular-weight hyaluronic acid products in patients with knee osteoarthritis. Randomized, double-blind, clinical trial comparing hyaluronic acid products of average molecular weights of 900,000 and 1.9 million.
Scientific Title:Acronym	A randomized, double-blind, clinical trial comparing high-molecular-weight hyaluronic acid products in patients with knee osteoarthritis.
Region	Japan

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

Objectives
Narrative objectives1	Improvement of knee joint pain and improvement of quality of life Comparison of efficacy of two high-molecular-weight hyaluronic acid products
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Japanese Knee Osteoarthritis Measure and Pain visual analog scale
Key secondary outcomes	Side effects and complications

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Pseudo-randomization

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	High molecular weight hyaluronic acid preparation with an average molecular weight of 900,000. The dosing interval is once a week for 5 weeks, up to 5 times. From 6 weeks to 24 weeks, the dosing interval is about twice a month.
Interventions/Control_2	High molecular weight hyaluronic acid preparation with an average molecular weight of 1.9 million. The dosing interval is once a week for 5 weeks, up to 5 times. From 6 weeks to 24 weeks, the dosing interval is about twice a month.
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	40 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Knee osteoarthritis Knee pain Kellgren - Lawrence Classification from grade 1 to grade 3
Key exclusion criteria	Cases where the treatment policy has changed due to the improvement or worsening of symptoms or the appearance of side effects. Cases where you cannot answer the questionnaire yourself. Cases where it is difficult to visit the hospital 5 times in a row.
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Hiroyuki Middle name Last name Onuma
Organization	Kawasaki Municipal Tama hospital
Division name	Orthopaedic surgery
Zip code	214-8525
Address	1-30-37, Shukugawara, Tama-ku, Kawasaki city
TEL	+81-(0)44-933-8111
Email	herrhiro@marianna-u.ac.jp

Public contact
Name of contact person	1st name Hiroyuki Middle name Last name Onuma
Organization	Kawasaki Municipal Tama hospital
Division name	Orthopaedic surgery
Zip code	214-8525
Address	1-30-37, Shukugawara, Tama-ku, Kawasaki city
TEL	+81-(0)44-933-8111
Homepage URL
Email	herrhiro@marianna-u.ac.jp

Sponsor
Institute	International University of Health and Welfare
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	None

Other related organizations
Co-sponsor	None
Name of secondary funder(s)	None

IRB Contact (For public release)
Organization	International University of Health and Welfare Hospital Ethics Review Committee
Address	537-3 Iguchi, Nasushiobara City, Tochigi Prefecture
Tel	0287-37-2221
Email	atakaku@iuhw.ac.jp

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	国際医療福祉大学病院/International University of Health and Welfare Hospital

Other administrative information
Date of disclosure of the study information	2020 Year 12 Month 01 Day

Related information
URL releasing protocol	N/A
Publication of results	Unpublished

Result
URL related to results and publications	N/A
Number of participants that the trial has enrolled	54
Results	54 people in total, 16 men, 38 women, 900,000 groups, 27 people, 1.9 million groups, 27 people, 2 deviations, 3 withdrawal of consent Both HA products alleviated walking pain and JKOM scores and their symptoms continued to improve with continued injections for 6 months.
Results date posted	2020 Year 12 Month 01 Day
Results Delayed
Results Delay Reason	None
Date of the first journal publication of results	2013 Year 04 Month 30 Day
Baseline Characteristics	Orthopedic outpatient with knee osteoarthritis
Participant flow	Participate if consent is obtained, explanation of treatment contents and research, explanation of how to proceed with research.
Adverse events	Swelling, redness, exacerbation of pain, systemic symptoms
Outcome measures	Japanese Knee Osteoarthritis Measure, visual anologue scale of pain
Plan to share IPD	None
IPD sharing Plan description	None

Progress
Recruitment status	Completed
Date of protocol fixation	2009 Year 08 Month 25 Day
Date of IRB	2009 Year 08 Month 25 Day
Anticipated trial start date	2009 Year 11 Month 30 Day
Last follow-up date	2013 Year 04 Month 30 Day
Date of closure to data entry	2013 Year 08 Month 31 Day
Date trial data considered complete	2013 Year 08 Month 31 Day
Date analysis concluded	2013 Year 08 Month 31 Day

Other
Other related information	Esumi Co., Ltd. Analysis consultant department statistician Takashi Fukushima

Management information
Registered date	2020 Year 12 Month 01 Day
Last modified on	2020 Year 12 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048628

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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