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

Status and phase

Completed

Phase 4

Conditions

Osteoarthritis of Knee

Treatments

Drug: Aceclofenac 100mg tab.

Drug: Pelubiprofen CR 45mg tab.

Study type

Interventional

Funder types

Industry

Identifiers

NCT02682524

DW_PlbCR_401

Details and patient eligibility

About

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

Enrollment

191 patients

Sex

All

Ages

35 to 80 years old

Volunteers

No Healthy Volunteers

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