To Compare the Efficacy and Safety of LAYLA in Osteoarthritis Patients

• Status: Completed
• Trial end date: 2013-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: PMG Pharm Co., Ltd

Criteria

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