Clinical Trial of YY1201 for Treatment of Osteoarthritis of the Knee

Study Overview
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Brief Summary
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This is a multicenter, randomized, double-blinded, parallel, placebo-controlled, phase I/IIa clinical trial of YY1201 for treatment of osteoarthritis of the knee.

Detailed Description
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phase I/IIa clinical trial of YY1201 for treatment of osteoarthritis of the knee

Official Title
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A Multicenter, Randomized, Double-blinded, Parallel, Placebo-controlled, Phase I/IIa Clinical Trial to Evaluate the Efficacy and Safety of Intra-articular YY1201 Once in the Treatment of Patients With Osteoarthritis of the Knee

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Drug: YY1201 2ml
* Drug: Placebo 2ml
* Drug: YY1201 3ml
* Drug: Placebo 3ml


Participation Criteria
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Eligibility Criteria
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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 Less than 30 minutes of morning stiffness Crepitus on active motion 4 bony tenderness Bony enlargement 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. 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. Patients who were injected HA at the target knee joint in recent 9 months. Patients who were injected HA at other parts of the knee joint in recent 6 months. Patients who were injected steroids into the intra-articular knee joint. Patients who were administrated steroids systemically by the oral medication (But, except inhalation) Patients who have joint effusion trouble were judged as a positive by tests like Patella tap test. 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. Patients who have an operation history about target knee joint. Patients who do the height weight aerobic exercise or anaerobic exercise. Patients who need to be administrated anticoagulant agent together(But, except 300mg daily dose aspirin) Patients who have hypersensitivity history about Investigational Product. 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. Patients who were injected other investigational product over a time within 30 days before participated in this clinical trail. Besides that, the patients who have difficulty to be participated in this clinical trial continuously by Principle Investigator (PI)'s decision.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: YY1201 2ml<br>YY1201 2ml | Drug: YY1201 2ml<br>* YY1201 2ml<br>|
| Experimental: YY1201 3ml<br>YY1201 3ml | Drug: YY1201 3ml<br>* YY1201 2ml<br>|
| Placebo Comparator: Placebo 2ml<br>Phosphate buffered saline 2ml | Drug: Placebo 2ml<br>* phosphate buffered saline 2ml<br>* Other names: Placebo comparator 1;|
| Placebo Comparator: Placebo 3ml<br>Phosphate buffered saline 3ml | Drug: Placebo 3ml<br>* phosphate buffered saline 3ml<br>* Other names: Placebo comparator 2;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation of the Weight-bearing pain(100mm-VAS) on the 4, 12 weeks after administration in comparison with baseline |  | Week 4 and Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation of the KOOS scales on the 4, 12 weeks after administration in comparison with baseline |  | Week 4 and Week 12 | 
| Variation of the rest pain(100mm-VAS) on the 4, 12 weeks after administration in comparison with baseline |  | Week 4 and Week 12 | 
| Motion pain (100mm-VAS) on the 4, 12 weeks after administration in comparison with baseline |  | Week 4 and Week 12 | 
| Patient global assessment (100mm-VAS) on the 4, 12 weeks after administration with baseline |  | Week 4 and Week 12 | 
| Investigator global assessment (100mm-VAS) on the 4, 12 weeks after administration |  | Week 4 and Week 12 | 
| Change of the swelling in the knee joint from baseline to 4, 12 weeks after administration |  | Week 4 and Week 12 | 
| Change of the tenderness on pressure in the knee joint from baseline to 4, 12 weeks after administration |  | Week 4 and Week 12 | 
| Rate of change of the Range Of Motion(ROM) in the knee joint on 4, 12 weeks after administration with baseline |  | Week 4 and Week 12 | 
| Use of rescue medication count and the total amount on 4, 12 weeks |  | Week 4 and Week 12 | 
| Response rate of the Weight-bearing pain on 12 weeks in comparison with baseline |  | Week 12 | 
| Response rate of the OMERACT-OARSI on 12 weeks in comparison with baseline |  | Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteoarthritis