Phase IV Clinical Trial to Evaluate the Efficacy and Safety of PlbCR and Aceclofenac in the Treatment of Patients With Osteoarthritis of the Knee
Phase 4
Completed
- Conditions
- Osteoarthritis of Knee
- Interventions
- Registration Number
- NCT02682524
- Lead Sponsor
- Daewon Pharmaceutical Co., Ltd.
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 191
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description test Pelubiprofen CR 45mg tab. - reference Aceclofenac 100mg tab. -
- Primary Outcome Measures
Name Time Method Change from baseline 100mm Pain VAS at 4weeks 4weeks
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Inha university hospital
š°š·Chung gu, Incheon, Korea, Republic of