Phase IV Clinical Trial to Evaluate the Efficacy and Safety of PlbCR and Aceclofenac in the Treatment of Patients With Osteoarthritis of the Knee

Study Overview
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Brief Summary
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A multicenter, randomized, double-blinded, parallel, active-controlled, phase IV clinical trial to evaluate the efficacy and safety of PlbCR and aceclofenac in the treatment of patients with osteoarthritis of the knee

Conditions
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Osteoarthritis of Knee

Intervention / Treatment
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* Drug: Pelubiprofen CR 45mg tab.
* Drug: Aceclofenac 100mg tab.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: both male and female who is over 35year-old and below 80year-old patient who diagnosed as Kellgren & Lawrence stage I III by X-ray osteoarthritis patient who is stable within 3months form starting this clinical trial patient who is over 40mm in 100mm Pain VAS at Visit 2 patient who agreed to participate this clinical trial spontaneously Exclusion Criteria: second osteoarthritis patient who has inflammatory disease which can effect efficacy outcomes such as bursitis, tenosynovitis, rheumatoid arthritis, etc. patient who diagnosed as gastric ulcer or GI disease by esophagogastroduodenoscopy patient who had joint surgery within 12months form screening visit of this clinical trial or planned to operate in this clinical trial period patient who has had artificial joint surgery of knee malignant tumor patient patient who has taken Psychopharmaceutical or Narcotic Analgesics over 3months continuously patient who took steroid by oral, inhalation or intraarticular injection within 3months form screening visit of this clinical trial patient who took intraarticular hyaluronic acid injection of knee within 2months form screening visit of this clinical trial patient who cannot take NSAIDs because of disease or medicine allergy of aspirin of other NSAIDs patient who has to handle his/her pain by or for CABG galactose intolerance, Lactose Intolerance or glucose-galactose malabsorption inflammatory bowel disease such as ulcerative colitis or Crohn's disease moderate renal disease moderate hepatic disease moderate hypertension(SBP=>160mmHg, DBP=>100mmHg) female who consents to contracept patient who is not appropriate for this clinical trial

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: test<br> | Drug: Pelubiprofen CR 45mg tab.<br> <br> |
| Active Comparator: reference<br> | Drug: Aceclofenac 100mg tab.<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline 100mm Pain VAS at 4weeks |  | 4weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline 100mm Pain VAS at 2weeks |  | 2weeks | 
| Change from baseline K-WOMAC Scale at 2weeks and 4weeks |  | 2weeks, 4weeks | 
| Patient Global Assessment |  | 4weeks |