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

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.

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis of the Knee
• Intervention / Treatment: Drug: LAYLA tablet; Drug: CENATONE tablet

• Study Type: Interventional
• Enrollment (Actual): 134
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital
  • Seoul, Korea, Republic of
    • Asan Medical Center
  • Seoul, Korea, Republic of
    • Inje University Seoul Paik Hospital
  • Seoul, Korea, Republic of
    • Chung-Ang University Hospital
  • Seoul, Korea, Republic of
    • The Catholic University of Korea, Seoul St. Mary's Hospital
  • Seoul, Korea, Republic of
    • SMG-SNU Boramae Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LAYLA; Drug : LAYLA tablet/bid	Drug: LAYLA tablet; 1 Tablet twice a day; Other Names: LAYLA 405.4mg
Active Comparator: CENATONE; Drug : CENATONE tablet/qd	Drug: CENATONE tablet; 2 Tablets once a day; Other Names: Nabumetone 500mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes from the baseline in 100mm Pain VAS	Baseline through week8

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: PMG Pharm Co., Ltd
• Investigators: Principal Investigator: Seung Baik Kang, MD, SMG-SNU Boramae Medical Center; Principal Investigator: Jeong Ku Ha, MD, Inje University; Principal Investigator: Han Jun Lee, MD, Chung-Ang University Hosptial, Chung-Ang University College of Medicine; Principal Investigator: Yong In, MD, The Catholic University of Korea; Principal Investigator: Jong Min Kim, MD, Asan Medical Center; Principal Investigator: Sahng Hoon Lee, MD, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2014
• Primary Completion (Actual): May 11, 2015
• Study Completion (Actual): May 30, 2016

Study Registration Dates

• First Submitted: January 28, 2014
• First Submitted That Met QC Criteria: January 29, 2014
• First Posted (Estimate): January 30, 2014

Study Record Updates

• Last Update Posted (Actual): September 20, 2017
• Last Update Submitted That Met QC Criteria: September 18, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Non-inferiority; LAYLA; 100mm pain VAS
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Cyclooxygenase 2 Inhibitors; Nabumetone
• Other Study ID Numbers: LAYLA_P4_NB