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 enrollmentAugust 2015

ConditionsOsteoarthritis of Knee

InterventionsPelubiprofen CR 45mg tab.Aceclofenac 100mg tab.

DrugsPelubiprofen CR 45mg tab.Aceclofenac 100mg tab.

Overview

Phase: Phase 4
Intervention: Pelubiprofen CR 45mg tab.
Conditions: Osteoarthritis of Knee
Sponsor: Daewon Pharmaceutical Co., Ltd.
Enrollment: 191
Locations: 1
Primary Endpoint: Change from baseline 100mm Pain VAS at 4weeks
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

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

Registry

clinicaltrials.gov

Start Date

August 2015

End Date

March 2016

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Daewon Pharmaceutical Co., Ltd.

Responsible Party

Sponsor

Eligibility 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