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Osteoarthritis, KneePhase 3NCT03561779

Clinical Trial of YYD302 (Phase3) for Treatment of Osteoarthritis of the Knee

A Phase 3 study testing YYD302 2ml and Active comparator: Synovian Inj. in people with Osteoarthritis, Knee, run by Yooyoung Pharmaceutical Co., Ltd. at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a randomized, double-blind, active-controlled, multi-center, phase 3 study to evaluate the safety and efficacy of intraarticular hyaluronic acid(YYD302) for osteoarthritis of the knee after 12 weeks of treatment and retreatment Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Osteoarthritis, Knee
What is being tested?
YYD302 2ml and Active comparator: Synovian Inj.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
184 participants
Where
1 siteSouth Korea
Study dates
21 Feb 2018to 4 Oct 2019
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • [Visit 1, 2 Inclusion Criteria]
  • Males or Females 40 years and older
  • According to the clinical diagnosis standard of the American College of Rheumatology (ACR), someone, diagnosed as a single/both sides of osteoarthritis, who corresponds to over 3 conditions of followings.
  • 1) Over 50 years of age 2) Less than 30 minutes of morning stiffness 3) Crepitus on active motion 4) 4 bony tenderness 5) Bony enlargement 6) Nopalpable warmth of synvium 3. Within 6 months from screening visit, someone who diagnosed with Kellgren \& Lawrence Grade I~III by the radioactive examination.
  • 4. By the Weight-bearing pain(100mm-VAS) examination, someone who has a outcome of the single or both sides of the osteoarthritis is over 40mm 5. Patient (No-responder) who has experienced steady pain in spite of dosing NSAIDs or other pain-killers in the past.
  • 6. Patient who can walk by themselves without helper like cane or walker etc. (If the patient who has used helper routinely from previous 6 months, evaluating the patient including the helper is possible. In this case, patient needs to use same helper continuously by end of the clinical trial test.) 7. Patient who agrees to participate in this clinical trial by themselves.
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  • [Visit 6, 7 Inclusion criteria] 1. According to the clinical diagnosis standard of the American College of Rheumatology (ACR), someone, diagnosed as a single/both sides of osteoarthritis, who corresponds to over 3 conditions of followings.
  • Over 50 years of age
  • Less than 30 minutes of morning stiffness
  • Crepitus on active motion
  • 4 bony tenderness
  • Bony enlargement
  • Nopalpable warmth of synvium 2. At Re-screening visit, someone who diagnosed with Kellgren \& Lawrence Grade I~III by the radioactive examination.
  • 3. Patient who can walk by themselves without helper like cane or walker etc. (If the patient who has used helper routinely from previous 6 months, evaluating the patient including the helper is possible. In this case, patient needs to use same helper continuously by end of the clinical trial test.) 4. Patient who are confirmed for Responder by efficacy at visit 5.

Who cannot join

  • Someone who has BMI≥32kg/m² at the screening visit.
  • Patient who has an experience dosing psychoactive drug, narcotic analgesic which can have an effect on pain sense over 3 months habitually.
  • Patient who has been administrated gastrointestinal drug(for example H₂-blockers, misoprostol or proton pump inhibitors) regularly, who can't stop injecting for clinical study period.
  • Patient has attended abnormal values from screening test(2 times excess at upper limit of the normal values at ALT, AST, BUN, Serum Creatinine).
  • Patient who has rheumarthritis or other inflammatory metabolic arthritis.
  • Patients having serious gastrointestinal, liver, renal, heart disease.
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  • When the inflammatory disease is occurred on joint area to patient like septic arthritis.
  • Patients having skin ailment at the injecting site of the joint region.
  • Patients having secondary osteoarthritis according to the Ochronosis, Hemochromatosis or systemic disease.
  • Patients who have severe pain like Sudek's atrophy, Paget's disease, Spinal disc herniation.
  • Poly-articular patients who have suffered seriously by osteoarthritis at other parts affect judge of the knee joint pain.
  • Patients who diagnosed clear interval disappearance at the knee joint by X-ray.
  • Patients who were administrated below drugs before baseline visit. 1) Patients who were injected HA at the target knee joint or other parts of knee joint in recent 9 months.
  • 2) Patients who were injected steroids into the intra-articular knee joint in recent 3 months 3) Patients who were administrated steroids systemically by the oral medication (But, except inhalation) 4) Patients who were administerated Osteoarthritis nutrition such as glucosamine/chondroichin sulfate or physical therapy or herbal remedy(acupuncture, yellowish swelling, moxa cautery) for the purpose of pain relief in recent 2 weeks 5) Patients who have administerated steroid/No-steriod NSAIDs or other pain relief drugs (patch or other external medicine) in recents 2 weeks except Acetaminophen or below 300mg/day of Asprin 14. Patients who have joint effusion trouble were judged as a positive by tests like Patella tap test.
  • 15. Patients who have target knee joint gotten surgical operation history including Arthroscopy within past one year (In case of having other side of knee joint or hip joint gotten surgical operation history, excepting the patients if there is possibility which can influence the target knee joint's appraisal.
  • 16. Patients who have an operation history about target knee joint. 17. Patients who do the height weight aerobic exercise or anaerobic exercise. 18. Patients who need to be administrated anticoagulant agent together(But, except 300mg daily dose aspirin) 19. Patients who have hypersensitivity history about Investigational Product.
  • 20. In the midst of women in their childbearing years, patients who disagree to do contraception by medically permitted method for 12 weeks from administrating investigational product.
  • The contraception by medically permitted method: Condom, In case of using injection or insertion, In case of installing a intrauterine contraception device etc.
  • 21. Pregnant and lactating women 22. Patients who were injected other investigational product over a time within 30 days before participated in this clinical trail.
  • 23. Besides that, the patients who have difficulty to be participated in this clinical trial continuously by Principle Investigator (PI)'s decision.
  • Exclusion criteria for Re-injection is except for 13-1) Re-injection date is followed by visit 7.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Samsung Medical Center

    Seoul

Other trials in South Korea

About this study

Official title: A Randomized, Double-blind, Active-controlled, Multi-center, Phase 3 Study to Evaluated the Safety and Efficacy of Intraarticular Hyalurinic Acid(YYD302) for Osteoarthritis of the Knee After 12 Weeks of Treatment and Retreatment

This is a randomized, double-blind, active-controlled, multi-center, phase 3 study to evaluate the safety and efficacy of intraarticular hyaluronic acid(YYD302) for osteoarthritis of the knee after 12 weeks of treatment and retreatment

Read the detailed description

First Injection: A multicenter, active-controlled, randomized, evaluator and subject bllinded, parallel, phase 3 study Re-Injection: A multicenter, active-controlled, randomized, parallel

Being tested
YYD302 2ml, Active comparator: Synovian Inj.
Keywords
Osteoarthritis
Medical subject headings
Osteoarthritis, Knee, Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • YYD302 2mlDrug

    YYD302 2ml

  • Active comparator: Synovian Inj.Drug

    Also called Synovian Inj.

    Active comparator: Synovian Inj.

Study groups in NCT03561779
Study groupRoleWhat they receive
YYD302ExperimentalYYD302 (2ml)
Receives: Drug: YYD302 2ml
Synovian Inj.Active comparatorSynovian Inj. (3ml)
Receives: Drug: Active comparator: Synovian Inj.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of change of the Weight-bearing pain(100mm-VAS) on 12 weeks after first injection in comparison with baseline

    Weight-bearing pain(100mm-VAS) assessed by the subject

    Measured: Change of the week 12 from baseline

Secondary outcomes (14)

  1. Rate of change of the Weight-bearing pain(100mm-VAS) on 2, 4 weeks after administration in comparison with baseline

    Weight-bearing pain(100mm-VAS) assessed by the subject

    Measured: Change of the week 2, 4 from baseline

  2. Rate of change of the KOOS scales on the 2, 4, 12 weeks after administration in comparison with baseline

    KOOS scales assessed by the subject

    Measured: Change of the week 2, 4, 12 from baseline

  3. Rate of change of the rest pain(100mm-VAS) on the 2, 4, 12 weeks after administration in comparison with baseline

    Rest pain(100mm-VAS) assessed by the subject

    Measured: Change of the week 2, 4, 12 from baseline

  4. Rate of change of the Motion pain (100mm-VAS) on the 2, 4, 12 weeks after administration in comparison with baseline

    Motion pain(100mm-VAS) assessed by the subject

    Measured: Change of the week 2, 4, 12 from baseline

  5. Patient global assessment (100mm-VAS) on the 2, 4, 12 weeks after administration with baseline

    Patient global assessment (100mm-VAS) assessed by the subject

    Measured: Change of the week 2, 4, 12 from baseline

  6. Investigator global assessment (100mm-VAS) on the 2, 4, 12 weeks after administration with baseline

    Patient global assessment (100mm-VAS) assessed by the investigator

    Measured: Change of the week 2, 4, 12 from baseline

  7. Change of the swelling in the knee joint from baseline to 2, 4, 12 weeks after administration

    Sweeling assessed by the investigator

    Measured: Change of the week 2, 4, 12 from baseline

  8. Change of the tenderness on pressure in the knee joint from baseline to 2, 4, 12 weeks after administration

    Tenderness on pressure assessed by the investigator

    Measured: Change of the week 2, 4, 12 from baseline

  9. Variation of the Range Of Motion(ROM) in the knee joint on 2, 4, 12 weeks after administration with baseline

    Range of motion assessed by the investigator

    Measured: Change of the week 2, 4, 12 from baseline

  10. Responder rate of the Weight-bearing pain on 12 weeks in comparison with baseline

    Responder rate of the Weight-bearing pain assessed by the investigator

    Measured: Change of the week 12 from baseline

  11. Responder rate of the OMERACT-OARSI on 12 weeks in comparison with baseline

    Responder rate of the OMERACT-OARSI assessed by the investigator

    Measured: Change of the week 12 from baseline

  12. Use of rescue medication count and the total amount on each visit after injection

    Use of rescue medication count and the total amount assessed by subject

    Measured: Change of the each visit(2, 4, 12, 24, 36 weeks) after injection

  13. The efficacy of secondary outcome 1~11 after 12 weeks(36weeks) compared with the Re-injection(24weeks) in re-injection subjects

    Each outcome assessed by the investigator or subject

    Measured: Change of the week 12 (36 weeks) after Re-injection(24weeks)

  14. The efficacy of secondary outcome 1~11 after baseline compared with 2, 4, 12, 24, 36 weeks in Re-injection subjects

    Each outcome assessed by the investigator or subject

    Measured: Change of the week 2, 4, 12, 24, 36 from baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jun 2018
  2. Study start21 Feb 2018
  3. Primary completion14 Jun 2019
  4. Study completion4 Oct 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The Subjects are injected investigational Product (YYD302 or Synovian Inj.)
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
184 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03561779
Sponsor's protocol ID
YY_YYD302_003
Status last verified
May 2021
First submitted
4 Jun 2018
Last updated
10 May 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Park YG, Ha CW, Yoo JH, Lee WS, Lee HJ, In Y, Bae KC, Shon OJ, Kim YM, Seon JK, Song SJ, Chang CB, Kim JM, Kim CW, Kim DH, Bae JH. Intra-Articular Injection of a Novel DVS Cross-Linked Hyaluronic Acid Manufactured by Biological Fermentation (YYD302) in Patients With Knee Osteoarthritis: A Double-Blind, Randomized, Multicenter, Noninferiority Study. Clin Ther. 2021 Nov;43(11):1843-1860. doi: 10.1016/j.clinthera.2021.09.005. Epub 2021 Nov 1.

    PubMed 34736768

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing YYD302 2ml and Active comparator: Synovian Inj. in people with Osteoarthritis, Knee, run by Yooyoung Pharmaceutical Co., Ltd. at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of change of the Weight-bearing pain(100mm-VAS) on 12 weeks after first injection in comparison with baseline (time frame: Change of the week 12 from baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03561779, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2021.

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