NCT02682524CompletedPhase 4
Phase IV Clinical Trial to Evaluate the Efficacy and Safety of PlbCR and Aceclofenac in the Treatment of Patients With Osteoarthritis of the Knee
Daewon Pharmaceutical Co., Ltd.1 site in 1 country191 target enrollmentStarted: August 2015Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 191
- Locations
- 1
- Primary Endpoint
- Change from baseline 100mm Pain VAS at 4weeks
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 35 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
test
Active Comparator
Intervention: Pelubiprofen CR 45mg tab. (Drug)
reference
Active Comparator
Intervention: Aceclofenac 100mg tab. (Drug)
Outcomes
Primary Outcomes
Change from baseline 100mm Pain VAS at 4weeks
Time Frame: 4weeks
Secondary Outcomes
- 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)
Investigators
Study Sites (1)
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