Osteoarthritis of the Knee
Conditions
Keywords
LAYLA, Non-inferiority, 100mm pain VAS
Brief summary
This is a randomized, double-blind study to compare the efficacy and safety of LAYLA tablet and CENATONE tablet in the treatment of osteoarthritis of the knee.
Interventions
DRUGLAYLA tablet
1 Tablet twice a day
DRUGCENATONE tablet
2 Tablets once a day
Sponsors
PMG Pharm Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients ≥40 and ≤80 years of age * Radiographic evidence of grade 1,2 or 3 osteoarthritis based on the Kellgren & Lawrence radiographic entry criteria * Stable osteoarthritis during 3 months * Score of 100mm Pain VAS ≤ 80mm at screening * Score of 100mm Pain VAS ≥ 40mm at baseline * Written consent form voluntarily
Exclusion criteria
* Disease of spine or other Lower limb joints that could affect fo evaluate the efficacy * History of surgery or arthroscopy of the study joint within 6 months * Trauma of study joint within 12 months * Medication of constantly(more than 1 week) corticosteroid by oral within 3 months * Diagnosed with psychical disorder, and taking medication * Medication of intra-articular injection within 3 months * Uncontrollable Hypertension patients at screening test * History of upper gastrointestinal ulceration within 6 months, History of upper gastrointestinal bleeding within 12 months * History of lower gastrointestinal bleeding within 12 months * History of coronary artery bypass, systemic lupus erythematosus or mixed connective tissue disease * Serum creatinine, ALT, AST, total bilirubin over ULN X 2.0 at screening test * History of hypersensitivity of LAYLA, CENATONE or NSAIDs * Participation in another clinical trials within 4 weeks * Medication of constantly (more than 1 week) narcotic analgesics within 3 months * Not consent about using effectual contraception method during trial * Pregnant or lactating woman * History of malignant tumor within 5 years * Investigator's judgment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes from the baseline in 100mm Pain VAS | Baseline through week8 |
Secondary
| Measure | Time frame |
|---|---|
| Changes rate from the baseline in 100mm Pain VAS | 8 weeks |
| Changes from the baseline in WOMAC | 8 Weeks |
| Changes from the baseline in EQ-5D | 8 Weeks |
| Changes in the patient self-assessed overall symptom score | 8 Weeks |
Countries
South Korea
Outcome results
None listed