Double-Blind, Double Dummy, Randomized Comparison Study to Evaluate the Efficacy and Safety of Valdecoxib 10 mg Once Daily and Naproxen 500 mg Twice Daily in Treating the Signs and Symptoms of Osteoarthritis of the Knee

Phase 3

Completed

• Conditions: Osteoarthritis; Knee
• Interventions: Drug: naproxen; Drug: valdecoxib

• Registration Number: NCT00652808
• Lead Sponsor: Pfizer

Brief Summary

This study was performed to demonstrate that treatment with valdecoxib 10 mg daily (QD) was at least as effective as with naproxen 500 mg twice daily (BID), a standard non-steroidal anti-inflammatory drug (NSAID), when taken for 6 weeks in Korean subjects with symptomatic osteoarthritis (OA) of the knee. Secondary objectives were to assess the overall safety and tolerability of valdecoxib 10 mg QD taken for 6 weeks in Korean subjects with symptomatic OA of the knee.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-05
• Study Completion: 2004-09
• Status Verified: 2008-04
• Study First Submitted: 2008-04-01
• Study First Submitted QC: 2008-04-03
• Study First Posted: 2008-04-04
• Last Update Submitted: 2008-04-07
• Last Update Posted: 2008-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 265

Inclusion Criteria

• Korean outpatients with symptomatic radiologic evidence of OA of the knee (diagnosed according to the modified American College Rheumatology criteria)
• Patient's Assessment of Arthritis Pain measurement of at least 40 mm on VAS
• Patients had not received any NSAIDs or analgesics within 2 days (within 4 days for subjects taking oxaprozin, piroxicam or full dose aspirin) prior to the Baseline Visit

Exclusion Criteria

• Diagnosis of inflammatory arthritis, gout, pseudogout, Paget's disease, or any chronic pain syndrome that, in the Investigator's opinion, would interfere with the assessment of the Index Knee
• Symptomatic anserine bursitis or acute joint trauma of the Index Knee
• Arthroscopy performed on the Index Knee within the past 12 months
• Complete loss of articular cartilage of the Index Knee
• Administration of oral, or intramuscular, intravenous, or soft tissue injections of corticosterosteroids within 4 weeks prior to screening visit
• Administration of intra-articular injection of corticosteroids or hyaluronic acid preparation in the Index Knee within 3 months or 6 months, respectively

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2	naproxen	-
Arm 1	valdecoxib	-

Primary Outcome Measures

Name	Time	Method
Patient's Assessment of Arthritis Pain using a Visual Analogue Scale (OA-Pain VAS)	Week 6

Secondary Outcome Measures

Name	Time	Method
WOMAC OA Physical Function	Week 2 and Week 6
WOMAC OA Stiffness Index	Week 2 and Week 6
Patient's Assessment of Arthritis Pain using a Visual Analogue Scale (OA-Pain VAS)	Week 2
Patient's Global Assessment of Arthritis Pain using a Visual Analogue Scale (OA-Pain VAS)	Week 2 and Week 6
adverse events	Continuous
Physician's Global Assessment of Arthritis Pain	Week 2 and Week 6
WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) Osteoarthritis (OA) Composite Index	Week 2 and Week 6
WOMAC OA Pain Index	Week 2 and Week 6

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇰🇷 Seoul, Korea, Republic of