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

Yooyoung Pharmaceutical Co., Ltd.1 site in 1 country184 target enrollmentFebruary 21, 2018

ConditionsOsteoarthritis, Knee

InterventionsYYD302 2ml

DrugsYYD302 2ml Active comparator: Synovian Inj.

Overview

Phase: Phase 3
Intervention: YYD302 2ml
Conditions: Osteoarthritis, Knee
Sponsor: Yooyoung Pharmaceutical Co., Ltd.
Enrollment: 184
Locations: 1
Primary Endpoint: Rate of change of the Weight-bearing pain(100mm-VAS) on 12 weeks after first injection in comparison with baseline
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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

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

Registry

clinicaltrials.gov

Start Date

February 21, 2018

End Date

October 4, 2019

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Yooyoung Pharmaceutical Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•\[Visit 1, 2 Inclusion Criteria\]
•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.
•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
•Within 6 months from screening visit, someone who diagnosed with Kellgren \& Lawrence Grade I\~III by the radioactive examination.
•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
•Patient (No-responder) who has experienced steady pain in spite of dosing NSAIDs or other pain-killers in the past.
•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.)
•Patient who agrees to participate in this clinical trial by themselves.
•\[Visit 6, 7 Inclusion criteria\]

Exclusion Criteria

•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.
•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.

Arms & Interventions

YYD302

YYD302 (2ml)

Intervention: YYD302 2ml

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

Rate of change of the KOOS scales on the 2, 4, 12 weeks after administration in comparison with baseline(Change of the week 2, 4, 12 from baseline)
Rate of change of the Motion pain (100mm-VAS) on the 2, 4, 12 weeks after administration in comparison with baseline(Change of the week 2, 4, 12 from baseline)
Rate of change of the Weight-bearing pain(100mm-VAS) on 2, 4 weeks after administration in comparison with baseline(Change of the week 2, 4 from baseline)
Rate of change of the rest pain(100mm-VAS) on the 2, 4, 12 weeks after administration in comparison with baseline(Change of the week 2, 4, 12 from baseline)
Change of the swelling in the knee joint from baseline to 2, 4, 12 weeks after administration(Change of the week 2, 4, 12 from baseline)
Variation of the Range Of Motion(ROM) in the knee joint on 2, 4, 12 weeks after administration with baseline(Change of the week 2, 4, 12 from baseline)
Responder rate of the Weight-bearing pain on 12 weeks in comparison with baseline(Change of the week 12 from baseline)
Responder rate of the OMERACT-OARSI on 12 weeks in comparison with baseline(Change of the week 12 from baseline)
The efficacy of secondary outcome 1~11 after baseline compared with 2, 4, 12, 24, 36 weeks in Re-injection subjects(Change of the week 2, 4, 12, 24, 36 from baseline)
Patient global assessment (100mm-VAS) on the 2, 4, 12 weeks after administration with baseline(Change of the week 2, 4, 12 from baseline)
Investigator global assessment (100mm-VAS) on the 2, 4, 12 weeks after administration with baseline(Change of the week 2, 4, 12 from baseline)
Change of the tenderness on pressure in the knee joint from baseline to 2, 4, 12 weeks after administration(Change of the week 2, 4, 12 from baseline)
Use of rescue medication count and the total amount on each visit after injection(Change of the each visit(2, 4, 12, 24, 36 weeks) after injection)
The efficacy of secondary outcome 1~11 after 12 weeks(36weeks) compared with the Re-injection(24weeks) in re-injection subjects(Change of the week 12 (36 weeks) after Re-injection(24weeks))