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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
PMG Pharm Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

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

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
January 28, 2014
Last Updated
September 18, 2017
Sponsor
PMG Pharm Co., Ltd
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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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