Clinical trial NCT01768468: To Compare the Efficacy and Safety of LAYLA in Osteoarthritis Patients
Official title: Double Blinded, Randomized, Active Drug Comparative, Multi-center, Phase IV Clinical Study to Compare the Efficacy and Safety of LAYLA in Osteoarthritis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis of the Knee
Keywords: LAYLA
Non-inferiority
100mm pain VAS
Lead sponsor: PMG Pharm Co., Ltd
Sponsor class: INDUSTRY
First posted: 2013-01-15
Enrollment: 124
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in 100mm Pain VAS
timeFrame: baseline throgh week 8
Secondary outcomes:
measure: Change from baseline in 100mm pain VAS
timeFrame: 12 weeks
measure: Change rate from baseline in 100mm Pain VAS
timeFrame: 8 weeks, 12 weeks
measure: Change from baseline in WOMAC
timeFrame: 8 weeks, 12 weeks
measure: Change from baseline in EQ-5D
timeFrame: 8 weeks, 12 weeks
measure: Change in the patient self-assessed & investigator-assessed overall symptom score
timeFrame: 8 weeks, 12 weeks
measure: Consumption of rescue medication
timeFrame: 4 times
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Keimyug University Dongsan Medical Center
city: Seoul
country: Korea, Republic of
facility: Hanyang University Guri Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: SMG-SNU Boramae Medical Center
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
Study officials:
affiliation: Hanyang University
name: Ye Soo Park
role: PRINCIPAL_INVESTIGATOR
affiliation: Samsung Medical Center
name: Chul Won Ha
role: PRINCIPAL_INVESTIGATOR
affiliation: Ajou University School of Medicine
name: Ye Yeon Won
role: PRINCIPAL_INVESTIGATOR
affiliation: SMG-SNU Boramae Medical Center
name: Jae Hyup Lee
role: PRINCIPAL_INVESTIGATOR
affiliation: Keimyug University Dongsan Medical Center
name: Byung Woo Min
role: PRINCIPAL_INVESTIGATOR
affiliation: Korea University Anam Hospital
name: Seung Beom Han
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ha CW, Park YB, Min BW, Han SB, Lee JH, Won YY, Park YS. Prospective, randomized, double-blinded, double-dummy and multicenter phase IV clinical study comparing the efficacy and safety of PG201 (Layla) and SKI306X in patients with osteoarthritis. J Ethnopharmacol. 2016 Apr 2;181:1-7. doi: 10.1016/j.jep.2016.01.029. Epub 2016 Jan 25.