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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000042608
Receipt No. R000048628
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.
Date of disclosure of the study information 2020/12/01
Last modified on 2020/12/01

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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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