To Compare the Efficacy and Safety of LAYLA in Osteoarthritis Patients of the Knee
Primary Purpose
Osteoarthritis of the Knee
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
LAYLA tablet
CENATONE tablet
Sponsored by

About this trial
This is an interventional treatment trial for Osteoarthritis of the Knee focused on measuring LAYLA, Non-inferiority, 100mm pain VAS
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
Sites / Locations
- Asan Medical Center
- Chung-Ang University Hospital
- Inje University Seoul Paik Hospital
- Seoul National University Hospital
- SMG-SNU Boramae Medical Center
- The Catholic University of Korea, Seoul ST. Mary's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
LAYLA
CENATONE
Arm Description
Drug : LAYLA tablet/bid
Drug : CENATONE tablet/qd
Outcomes
Primary Outcome Measures
Changes from the baseline in 100mm Pain VAS
Secondary Outcome Measures
Changes rate from the baseline in 100mm Pain VAS
Changes from the baseline in WOMAC
Changes from the baseline in EQ-5D
Changes in the patient self-assessed overall symptom score
Full Information
NCT ID
NCT02049606
First Posted
January 28, 2014
Last Updated
September 18, 2017
Sponsor
PMG Pharm Co., Ltd
1. Study Identification
Unique Protocol Identification Number
NCT02049606
Brief Title
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
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
February 24, 2014 (Actual)
Primary Completion Date
May 11, 2015 (Actual)
Study Completion Date
May 30, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PMG Pharm Co., Ltd
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis of the Knee
Keywords
LAYLA, Non-inferiority, 100mm pain VAS
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
134 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LAYLA
Arm Type
Experimental
Arm Description
Drug : LAYLA tablet/bid
Arm Title
CENATONE
Arm Type
Active Comparator
Arm Description
Drug : CENATONE tablet/qd
Intervention Type
Drug
Intervention Name(s)
LAYLA tablet
Other Intervention Name(s)
LAYLA 405.4mg
Intervention Description
1 Tablet twice a day
Intervention Type
Drug
Intervention Name(s)
CENATONE tablet
Other Intervention Name(s)
Nabumetone 500mg
Intervention Description
2 Tablets once a day
Primary Outcome Measure Information:
Title
Changes from the baseline in 100mm Pain VAS
Time Frame
Baseline through week8
Secondary Outcome Measure Information:
Title
Changes rate from the baseline in 100mm Pain VAS
Time Frame
8 weeks
Title
Changes from the baseline in WOMAC
Time Frame
8 Weeks
Title
Changes from the baseline in EQ-5D
Time Frame
8 Weeks
Title
Changes in the patient self-assessed overall symptom score
Time Frame
8 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seung Baik Kang, MD
Organizational Affiliation
SMG-SNU Boramae Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jeong Ku Ha, MD
Organizational Affiliation
Inje University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Han Jun Lee, MD
Organizational Affiliation
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yong In, MD
Organizational Affiliation
The Catholic University of Korea
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jong Min Kim, MD
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sahng Hoon Lee, MD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Chung-Ang University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Inje University Seoul Paik Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
SMG-SNU Boramae Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, Seoul ST. Mary's Hospital
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
To Compare the Efficacy and Safety of LAYLA in Osteoarthritis Patients of the Knee
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