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

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 Overview

• Status: Completed
• Conditions: Osteoarthritis of Knee
• Intervention / Treatment: Drug: Pelubiprofen CR 45mg tab.; Drug: Aceclofenac 100mg tab.

• Study Type: Interventional
• Enrollment (Actual): 191
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Incheon
    • Chung gu, Incheon, Korea, Republic of
      • Inha University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: test	Drug: Pelubiprofen CR 45mg tab.
Active Comparator: reference	Drug: Aceclofenac 100mg tab.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline 100mm Pain VAS at 4weeks	4weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Daewon Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: October 12, 2015
• First Submitted That Met QC Criteria: February 10, 2016
• First Posted (Estimate): February 15, 2016

Study Record Updates

• Last Update Posted (Estimate): October 10, 2016
• Last Update Submitted That Met QC Criteria: October 7, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Aceclofenac
• Other Study ID Numbers: DW_PlbCR_401