UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042608
Receipt number 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 12:21:57

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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 or person

Institute

International University of Health and Welfare

Institute

Department

Personal name



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

Value
https://center6.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