To Compare the Efficacy and Safety of LAYLA in Osteoarthritis Patients of the Knee

Overview

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.

Full Title of Study: “Double Blinded, Randomized, Active Drug Comparative, Multi-center, Phase Ⅳ Clinical Study to Compare the Efficacy and Safety of LAYLA in Osteoarthritis Patients of the Knee.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: May 11, 2015

Interventions

  • Drug: LAYLA tablet
    • 1 Tablet twice a day
  • Drug: CENATONE tablet
    • 2 Tablets once a day

Arms, Groups and Cohorts

  • Experimental: LAYLA
    • Drug : LAYLA tablet/bid
  • Active Comparator: CENATONE
    • Drug : CENATONE tablet/qd

Clinical Trial Outcome Measures

Primary Measures

  • Changes from the baseline in 100mm Pain VAS
    • Time Frame: Baseline through week8

Secondary Measures

  • Changes rate from the baseline in 100mm Pain VAS
    • Time Frame: 8 weeks
  • Changes from the baseline in WOMAC
    • Time Frame: 8 Weeks
  • Changes from the baseline in EQ-5D
    • Time Frame: 8 Weeks
  • Changes in the patient self-assessed overall symptom score
    • Time Frame: 8 Weeks

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • PMG Pharm Co., Ltd
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Seung Baik Kang, MD, Principal Investigator, SMG-SNU Boramae Medical Center
    • Jeong Ku Ha, MD, Principal Investigator, Inje University
    • Han Jun Lee, MD, Principal Investigator, Chung-Ang University Hosptial, Chung-Ang University College of Medicine
    • Yong In, MD, Principal Investigator, The Catholic University of Korea
    • Jong Min Kim, MD, Principal Investigator, Asan Medical Center
    • Sahng Hoon Lee, MD, Principal Investigator, Seoul National University Hospital

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