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

NCT ID: NCT02682524

Last Updated: 2016-10-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 191 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2016-03-31

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

Conditions

Osteoarthritis of Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

test

Group Type: ACTIVE_COMPARATOR

Pelubiprofen CR 45mg tab.

Intervention Type: DRUG

reference

Group Type: ACTIVE_COMPARATOR

Aceclofenac 100mg tab.

Intervention Type: DRUG

Interventions

Pelubiprofen CR 45mg tab.

Intervention Type: DRUG

Aceclofenac 100mg tab.

Intervention Type: DRUG

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
• 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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Daewon Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Inha university hospital

Chung Gu, Incheon, South Korea

Countries

South Korea

Other Identifiers

DW_PlbCR_401

Identifier Type: -

Identifier Source: org_study_id