Overview
To Compare the Efficacy and Safety of LAYLA in Osteoarthritis Patients of the Knee
Status:
Completed
Completed
Trial end date:
2016-05-30
2016-05-30
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 4Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
PMG Pharm Co., LtdTreatments:
Nabumetone
Criteria
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