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

Condition(s) targeted: Osteoarthritis; Knee

Intervention: valdecoxib (Drug); naproxen (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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.

Official title: Double-Blind, Double Dummy, Randomized Comparison Study to Evaluate the Efficacy and Safety of Valdecoxib 10 mg QD and Naproxen 500 mg BID in Treating the Signs and Symptoms of Osteoarthritis of the Knee

Study design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Primary outcome: Patient's Assessment of Arthritis Pain using a Visual Analogue Scale (OA-Pain VAS)

Secondary outcome:

WOMAC OA Physical Function

WOMAC OA Stiffness Index

Patient's Assessment of Arthritis Pain using a Visual Analogue Scale (OA-Pain VAS)

Patient's Global Assessment of Arthritis Pain using a Visual Analogue Scale (OA-Pain VAS)

adverse events

Physician's Global Assessment of Arthritis Pain

WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) Osteoarthritis (OA) Composite Index

WOMAC OA Pain Index

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Pfizer Investigational Site, Seoul 137-701, Korea, Republic of

Pfizer Investigational Site, Seoul 110-744, Korea, Republic of

Pfizer Investigational Site, Seoul 138-736, Korea, Republic of

Pfizer Investigational Site, Anyang 431-070, Korea, Republic of

Pfizer Investigational Site, Seoul 152-703, Korea, Republic of

Pfizer Investigational Site, Pusan 602-739, Korea, Republic of

Pfizer Investigational Site, Gwangju 501-757, Korea, Republic of

Pfizer Investigational Site, Incheon 405-760, Korea, Republic of

To obtain contact information for a study center near you, click here.

Link to ClinicalStudyResults.org posting:

Starting date: May 2004
Ending date: September 2004
Last updated: April 7, 2008