To Compare the Efficacy and Safety of LAYLA in Osteoarthritis Patients

PMG Pharm

Status and phase

Completed

Phase 4

Conditions

Osteoarthritis of the Knee

Treatments

Drug: JOINS tablet

Drug: LAYLA tablet

Study type

Interventional

Funder types

Industry

Identifiers

NCT01768468

LAYLA-P4

Details and patient eligibility

About

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.

Enrollment

124 patients

Sex

All

Ages

40 to 80 years old

Volunteers

No Healthy Volunteers

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