Osteoarthritis of Knee
Conditions
Brief summary
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
Interventions
DRUGPelubiprofen CR 45mg tab.
DRUGAceclofenac 100mg tab.
Sponsors
Daewon Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
35 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline 100mm Pain VAS at 4weeks | 4weeks |
Secondary
| Measure | 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 |
Countries
South Korea
Outcome results
None listed