To Compare the Efficacy and Safety of LAYLA in Osteoarthritis Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01768468
Recruitment Status : Completed
First Posted : January 15, 2013
Last Update Posted : October 14, 2013
Information provided by (Responsible Party):
PMG Pharm Co., Ltd

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.

Condition or disease Intervention/treatment Phase
Osteoarthritis of the Knee Drug: LAYLA tablet Drug: JOINS tablet Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : October 2012
Actual Primary Completion Date : June 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Change in 100mm Pain VAS [ Time Frame: baseline throgh week 8 ]

Secondary Outcome Measures :
  1. Change from baseline in 100mm pain VAS [ Time Frame: 12 weeks ]
  2. Change rate from baseline in 100mm Pain VAS [ Time Frame: 8 weeks, 12 weeks ]
  3. Change from baseline in WOMAC [ Time Frame: 8 weeks, 12 weeks ]
  4. Change from baseline in EQ-5D [ Time Frame: 8 weeks, 12 weeks ]
  5. Change in the patient self-assessed & investigator-assessed overall symptom score [ Time Frame: 8 weeks, 12 weeks ]
  6. Consumption of rescue medication [ Time Frame: 4 times ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01768468

Korea, Republic of
Keimyug University Dongsan Medical Center
Daegu, Korea, Republic of
Hanyang University Guri Hospital
Seoul, Korea, Republic of
Korea University Anam Hospital
Seoul, Korea, Republic of
Samsung Medical Center
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
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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: PMG Pharm Co., Ltd Identifier: NCT01768468     History of Changes
Other Study ID Numbers: LAYLA-P4
First Posted: January 15, 2013    Key Record Dates
Last Update Posted: October 14, 2013
Last Verified: October 2013

Keywords provided by PMG Pharm Co., Ltd:
100mm pain VAS

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