To Compare the Efficacy and Safety of LAYLA in Osteoarthritis Patients

Phase 4

Completed

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

• Registration Number: NCT01768468
• 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 Joins tablet in the treatment of osteoarthritis of the knee.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2013-01-11
• Study First Submitted QC: 2013-01-14
• Study First Posted: 2013-01-15
• Primary Completion: 2013-06
• Study Completion: 2013-09
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-11
• Last Update Posted: 2013-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LAYLA	LAYLA tablet	Drug : LAYLA tablet/ bid
JOINS	JOINS tablet	Drug : JOINS tablet/ tid

Primary Outcome Measures

Name	Time	Method
Change in 100mm Pain VAS	baseline throgh week 8

Secondary Outcome Measures

Name	Time	Method
Change from baseline in 100mm pain VAS	12 weeks
Change rate from baseline in 100mm Pain VAS	8 weeks, 12 weeks
Change from baseline in WOMAC	8 weeks, 12 weeks
Change from baseline in EQ-5D	8 weeks, 12 weeks
Change in the patient self-assessed & investigator-assessed overall symptom score	8 weeks, 12 weeks
Consumption of rescue medication	4 times

Trial Locations

Locations (6)

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

Ajou University Hospital; 🇰🇷 Suwon, Korea, Republic of

Keimyug University Dongsan Medical Center; 🇰🇷 Daegu, Korea, Republic of

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

Hanyang University Guri Hospital; 🇰🇷 Seoul, Korea, Republic of

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