To Compare the Efficacy and Safety of LAYLA in Osteoarthritis Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
PMG Pharm Co., Ltd
ClinicalTrials.gov Identifier:
NCT01768468
First received: January 11, 2013
Last updated: October 11, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Osteoarthritis of the Knee
Drug: LAYLA tablet
Drug: JOINS tablet
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by PMG Pharm Co., Ltd:

Primary Outcome Measures:
  • Change in 100mm Pain VAS [ Time Frame: baseline throgh week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in 100mm pain VAS [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Change rate from baseline in 100mm Pain VAS [ Time Frame: 8 weeks, 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in WOMAC [ Time Frame: 8 weeks, 12 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in EQ-5D [ Time Frame: 8 weeks, 12 weeks ] [ Designated as safety issue: No ]
  • Change in the patient self-assessed & investigator-assessed overall symptom score [ Time Frame: 8 weeks, 12 weeks ] [ Designated as safety issue: No ]
  • Consumption of rescue medication [ Time Frame: 4 times ] [ Designated as safety issue: No ]

Enrollment: 124
Study Start Date: October 2012
Study Completion Date: September 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LAYLA
Drug : LAYLA tablet/ bid
Drug: LAYLA tablet
1 tablet twice a day
Other Name: LAYLA 405.4mg
Active Comparator: JOINS
Drug : JOINS tablet/ tid
Drug: JOINS tablet
1 tablet at each time, 3 times a day
Other Name: JOINS 200mg

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01768468

Locations
Korea, Republic of
Keimyug University Dongsan Medical Center
Daegu, Korea, Republic of
Hanyang University Guri Hospital
Seoul, Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Korea University Anam Hospital
Seoul, Korea, Republic of
SMG-SNU Boramae Medical Center
Seoul, Korea, Republic of
Ajou University Hospital
Suwon, Korea, Republic of
Sponsors and Collaborators
PMG Pharm Co., Ltd
Investigators
Principal Investigator: Ye Soo Park Hanyang University
Principal Investigator: Chul Won Ha Samsung Medical Center
Principal Investigator: Ye Yeon Won Ajou University School of Medicine
Principal Investigator: Jae Hyup Lee SMG-SNU Boramae Medical Center
Principal Investigator: Byung Woo Min Keimyug University Dongsan Medical Center
Principal Investigator: Seung Beom Han Korea University Anam Hospital
  More Information

No publications provided

Responsible Party: PMG Pharm Co., Ltd
ClinicalTrials.gov Identifier: NCT01768468     History of Changes
Other Study ID Numbers: LAYLA-P4
Study First Received: January 11, 2013
Last Updated: October 11, 2013
Health Authority: Korea: Institutional Review Board

Keywords provided by PMG Pharm Co., Ltd:
LAYLA
Non-inferiority
100mm pain VAS

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on April 22, 2014