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 Joins tablet in the treatment of osteoarthritis of the knee.
Interventions
DRUGLAYLA tablet
1 tablet twice a day
DRUGJOINS tablet
1 tablet at each time, 3 times 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 ≤ 80years of age * Radiographic evidence of grade 2 or 3 osteoarthritis based on the Kellgren & Lawrene radiographic entry criteria * Stable osteoarthritis during 3 months * Score of 100mm pain VAS ≤ 80mm at screening * Score of 100mm pain VAS ≥ 50mm at baseline * Written consent form voluntarily
Exclusion criteria
* Disease of spine or other Lower limb joints that could affect to 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 * Medication of intra-articular injection within 3 months * Diagnosed with psychical disorder, and taking medication * History of upper gastrointestinal ulceration within 6 months * History of upper gastrointestinal bleeding within 12 months * Serum creatinine, ALT, AST, total bilirubin over UNL X 2.0 at screening test * History of hypersensitivity to LAYLA, JOINS, 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 * Investigator's judgment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in 100mm Pain VAS | baseline throgh week 8 |
Secondary
| Measure | Time frame |
|---|---|
| Change rate from baseline in 100mm Pain VAS | 8 weeks, 12 weeks |
| Change from baseline in WOMAC | 8 weeks, 12 weeks |
| Change from baseline in 100mm pain VAS | 12 weeks |
| Change in the patient self-assessed & investigator-assessed overall symptom score | 8 weeks, 12 weeks |
| Consumption of rescue medication | 4 times |
| Change from baseline in EQ-5D | 8 weeks, 12 weeks |
Countries
South Korea
Outcome results
None listed