To Compare the Efficacy and Safety of LAYLA in Osteoarthritis Patients
NCT ID: NCT01768468
Last Updated: 2013-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
124 participants
INTERVENTIONAL
2012-10-31
2013-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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LAYLA
Drug : LAYLA tablet/ bid
LAYLA tablet
1 tablet twice a day
JOINS
Drug : JOINS tablet/ tid
JOINS tablet
1 tablet at each time, 3 times a day
Interventions
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LAYLA tablet
1 tablet twice a day
JOINS tablet
1 tablet at each time, 3 times a day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
80 Years
ALL
No
Sponsors
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PMG Pharm Co., Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Ye Soo Park
Role: PRINCIPAL_INVESTIGATOR
Hanyang University
Chul Won Ha
Role: PRINCIPAL_INVESTIGATOR
Samsung Medical Center
Ye Yeon Won
Role: PRINCIPAL_INVESTIGATOR
Ajou University School of Medicine
Jae Hyup Lee
Role: PRINCIPAL_INVESTIGATOR
SMG-SNU Boramae Medical Center
Byung Woo Min
Role: PRINCIPAL_INVESTIGATOR
Keimyug University Dongsan Medical Center
Seung Beom Han
Role: PRINCIPAL_INVESTIGATOR
Korea University Anam Hospital
Locations
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Keimyug University Dongsan Medical Center
Daegu, , South Korea
Hanyang University Guri Hospital
Seoul, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
SMG-SNU Boramae Medical Center
Seoul, , South Korea
Ajou University Hospital
Suwon, , South Korea
Countries
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References
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Ha CW, Park YB, Min BW, Han SB, Lee JH, Won YY, Park YS. Prospective, randomized, double-blinded, double-dummy and multicenter phase IV clinical study comparing the efficacy and safety of PG201 (Layla) and SKI306X in patients with osteoarthritis. J Ethnopharmacol. 2016 Apr 2;181:1-7. doi: 10.1016/j.jep.2016.01.029. Epub 2016 Jan 25.
Other Identifiers
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LAYLA-P4
Identifier Type: -
Identifier Source: org_study_id