![]() |
UMIN-CTR Clinical Trial |
|
![]() |
![]() |
![]() |
![]() |
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 |
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 |
|
Condition | ||
Condition | knee osteoarthritis | |
Classification by specialty |
|
|
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 |
|
|
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 |
|
|||
Age-upper limit |
|
|||
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 |
|
||||||
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 | ||||||
herrhiro@marianna-u.ac.jp |
Public contact | |||||||
Name of contact person |
|
||||||
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 | |||||||
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 |
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 |
|
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 |
|
||||||
Results Delayed | |||||||
Results Delay Reason | None | ||||||
Date of the first journal publication of results |
|
||||||
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 |
|
||||||
Date of IRB |
|
||||||
Anticipated trial start date |
|
||||||
Last follow-up date |
|
||||||
Date of closure to data entry |
|
||||||
Date trial data considered complete |
|
||||||
Date analysis concluded |
|
Other | |
Other related information | Esumi Co., Ltd.
Analysis consultant department statistician Takashi Fukushima |
Management information | |||||||
Registered date |
|
||||||
Last modified on |
|
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 |