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

Phase 4

Completed

• Conditions: Osteoarthritis of the Knee
• Interventions: Drug: CENATONE tablet; Drug: LAYLA tablet

• Registration Number: NCT02049606
• Lead Sponsor: PMG Pharm Co., Ltd

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-01-28
• Study First Submitted QC: 2014-01-29
• Study First Posted: 2014-01-30
• Study Start: 2014-02-24
• Primary Completion: 2015-05-11
• Study Completion: 2016-05-30
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-18
• Last Update Posted: 2017-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 134

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CENATONE	CENATONE tablet	Drug : CENATONE tablet/qd
LAYLA	LAYLA tablet	Drug : LAYLA tablet/bid

Primary Outcome Measures

Name	Time	Method
Changes from the baseline in 100mm Pain VAS	Baseline through week8

Secondary Outcome Measures

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

Trial Locations

Locations (6)

Inje University Seoul Paik Hospital; 🇰🇷 Seoul, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

Chung-Ang University Hospital; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

SMG-SNU Boramae Medical Center; 🇰🇷 Seoul, Korea, Republic of

The Catholic University of Korea, Seoul ST. Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of