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

• Status: Completed
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daewon Pharmaceutical Co., Ltd.
• Treatments: Aceclofenac

Criteria

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