- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03561779
Clinical Trial of YYD302 (Phase3) for Treatment of Osteoarthritis of the Knee
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Seoul, Korea, Republic of
- Samsung Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
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.
[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.
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.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: YYD302
YYD302 (2ml)
|
YYD302 2ml
|
Active Comparator: Synovian Inj.
Synovian Inj. (3ml)
|
Active comparator: Synovian Inj.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Change of the week 12 from baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of change of the Weight-bearing pain(100mm-VAS) on 2, 4 weeks after administration in comparison with baseline
Time Frame: Change of the week 2, 4 from baseline
|
Weight-bearing pain(100mm-VAS) assessed by the subject
|
Change of the week 2, 4 from baseline
|
Rate of change of the KOOS scales on the 2, 4, 12 weeks after administration in comparison with baseline
Time Frame: Change of the week 2, 4, 12 from baseline
|
KOOS scales assessed by the subject
|
Change of the week 2, 4, 12 from baseline
|
Rate of change of the rest pain(100mm-VAS) on the 2, 4, 12 weeks after administration in comparison with baseline
Time Frame: Change of the week 2, 4, 12 from baseline
|
Rest pain(100mm-VAS) assessed by the subject
|
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
Time Frame: Change of the week 2, 4, 12 from baseline
|
Motion pain(100mm-VAS) assessed by the subject
|
Change of the week 2, 4, 12 from baseline
|
Patient global assessment (100mm-VAS) on the 2, 4, 12 weeks after administration with baseline
Time Frame: Change of the week 2, 4, 12 from baseline
|
Patient global assessment (100mm-VAS) assessed by the subject
|
Change of the week 2, 4, 12 from baseline
|
Investigator global assessment (100mm-VAS) on the 2, 4, 12 weeks after administration with baseline
Time Frame: Change of the week 2, 4, 12 from baseline
|
Patient global assessment (100mm-VAS) assessed by the investigator
|
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
Time Frame: Change of the week 2, 4, 12 from baseline
|
Sweeling assessed by the investigator
|
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
Time Frame: Change of the week 2, 4, 12 from baseline
|
Tenderness on pressure assessed by the investigator
|
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
Time Frame: Change of the week 2, 4, 12 from baseline
|
Range of motion assessed by the investigator
|
Change of the week 2, 4, 12 from baseline
|
Responder rate of the Weight-bearing pain on 12 weeks in comparison with baseline
Time Frame: Change of the week 12 from baseline
|
Responder rate of the Weight-bearing pain assessed by the investigator
|
Change of the week 12 from baseline
|
Responder rate of the OMERACT-OARSI on 12 weeks in comparison with baseline
Time Frame: Change of the week 12 from baseline
|
Responder rate of the OMERACT-OARSI assessed by the investigator
|
Change of the week 12 from baseline
|
Use of rescue medication count and the total amount on each visit after injection
Time Frame: Change of the each visit(2, 4, 12, 24, 36 weeks) after injection
|
Use of rescue medication count and the total amount assessed by subject
|
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
Time Frame: Change of the week 12 (36 weeks) after Re-injection(24weeks)
|
Each outcome assessed by the investigator or subject
|
Change of the week 12 (36 weeks) after Re-injection(24weeks)
|
The efficacy of secondary outcome 1~11 after baseline compared with 2, 4, 12, 24, 36 weeks in Re-injection subjects
Time Frame: Change of the week 2, 4, 12, 24, 36 from baseline
|
Each outcome assessed by the investigator or subject
|
Change of the week 2, 4, 12, 24, 36 from baseline
|
Collaborators and Investigators
Investigators
- Principal Investigator: Chul-Won Ha, M.D, Samsung Medical Center, Department of Internal Medicine
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- YY_YYD302_003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Osteoarthritis, Knee
-
LifeBridge HealthMicroPort Orthopedics Inc.; Rubin Institute for Advanced OrthopedicsRecruitingKnee Osteoarthritis | Osteoarthritis, Knee | Knee Pain Chronic | Arthropathy of Knee Joint | Knee Disease | Osteoarthritis Knees Both | Osteoarthritis Knee Left | Osteoarthritis Knee RightUnited States
-
University Hospital, Clermont-FerrandSanofiCompletedKnee Osteoarthritis (Knee OA)France
-
Joseph E. BroylesCompletedDegenerative Lesion of Articular Cartilage of Knee | Degeneration; Articular Cartilage, Knee | Unilateral Primary Osteoarthritis of Knee | Osteoarthritis Knee
-
The Hong Kong Polytechnic UniversityCompleted
-
Federal University of São PauloCompletedKNEE OSTEOARTHRITISBrazil
-
Jiangsu XinChen-Techfields Pharma Co., LTD.Completed
-
Tianjin XinChen-Techfields Pharma Co., LTD.Completed
-
Eun Jung KimMinistry of Health & Welfare, Korea; Semyung UniversityUnknownOsteoarthritis KneeKorea, Republic of
-
Thammasat UniversityCompletedPrimary Knee OsteoarthritisThailand
-
Galderma R&DCompletedUnilateral Knee OsteoarthritisUnited Kingdom
Clinical Trials on YYD302 2ml
-
Yooyoung Pharmaceutical Co., Ltd.CompletedOsteoarthritis, KneeKorea, Republic of
-
Biosplice Therapeutics, Inc.CompletedModerate to Severe OsteoarthritisUnited States
-
Yooyoung Pharmaceutical Co., Ltd.WithdrawnOsteoarthritis, KneeKorea, Republic of
-
Ahmad Jabir RahyussalimUnknownLow Back Pain | Degenerative Disc Disease | Disc DegenerationIndonesia
-
National Taiwan University HospitalCompleted
-
Centre Hospitalier du Centre du ValaisUnknownThrombosis | Malfunction; Catheter | Mechanical Complication of Hemodialysis CatheterSwitzerland
-
Medipost Co Ltd.CompletedAlzheimer's DiseaseKorea, Republic of
-
Northwestern UniversityRecruiting
-
Medipost Co Ltd.CompletedAlzheimer's DiseaseKorea, Republic of
-
Novartis PharmaceuticalsNot yet recruitingRheumatoid Arthritis | Systemic Lupus Erythematosus | Sjögrens Disease