Clinical trial NCT02049606: To Compare the Efficacy and Safety of LAYLA in Osteoarthritis Patients of the Knee
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 of the Knee.
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: 2014-01-30
Enrollment: 134
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 CENATONE tablet in the treatment of osteoarthritis of the knee.


Eligibility criteria: 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

Primary outcomes:
measure: Changes from the baseline in 100mm Pain VAS
timeFrame: Baseline through week8
Secondary outcomes:
measure: Changes rate from the baseline in 100mm Pain VAS
timeFrame: 8 weeks
measure: Changes from the baseline in WOMAC
timeFrame: 8 Weeks
measure: Changes from the baseline in EQ-5D
timeFrame: 8 Weeks
measure: Changes in the patient self-assessed overall symptom score
timeFrame: 8 Weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hospital
city: Seoul
country: Korea, Republic of
facility: Inje University Seoul Paik Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: SMG-SNU Boramae Medical Center
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul ST. Mary's Hospital
Study officials:
affiliation: SMG-SNU Boramae Medical Center
name: Seung Baik Kang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Inje University
name: Jeong Ku Ha, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
name: Han Jun Lee, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Catholic University of Korea
name: Yong In, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Asan Medical Center
name: Jong Min Kim, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul National University Hospital
name: Sahng Hoon Lee, MD
role: PRINCIPAL_INVESTIGATOR
References: