A Double-Blind, Double Dummy, Randomized Comparison Study Of The Efficacy And Safety Of Valdecoxib 10mg Once Daily And Naproxen 500mg Twice Daily In Treating The Signs And Symptoms Of Osteoarthritis Of The Knee Or Hip In Taiwan

Condition(s) targeted: Osteoarthritis

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

To evaluate the efficacy, safety, and tolerability of valdecoxib by comparing valdecoxib 10 mg daily (QD) with naproxen 500 mg twice daily (BID) in treating the signs and symptoms of osteoarthritis (OA) of the knee or hip. The study was designed to collect comparative information for the local population (Taiwan).

Official title: A Double-Blind, Double Dummy, Randomized Comparison Study Of The Efficacy And Safety Of Valdecoxib 10mg QD And Naproxen 500mg BID In Treating The Signs And Symptoms Of Osteoarthritis Of The Knee Or Hip In Taiwan

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

Primary outcome: Patient's Assessment of Arthritis Pain (Osteoarthritis-Pain VAS)

Secondary outcome:

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

WOMAC OA physical function

WOMAC OA pain index

WOMAC OA stiffness index

Patient's Assessment of Arthritis Pain (Osteoarthritis-Pain VAS)

Patient's Global Assessment of Arthritis

Physician's Global Assessment of Arthritis

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

Criteria:

Inclusion Criteria:

- The diagnosis of hip OA, which was having hip pain and meeting criteria for at least 2

of the following: a. Westergren erythrocyte sedimentation rate of < 20 mm/hr; b. radiographic femoral or acetabular osteophytes or c. radiographic joint space narrowing

- Knee OA diagnosis required diagnosing (by modified American College of Rheumatology

criteria) OA of the knee with pain plus at least one of the following: a. Age> 50 years old, b. Stiffness < 30 minutes, c. crepitus on active motion and radiographic evidence of OA of the knee, defined as presence of osteophytes or joint space narrowing

- Symptomatic OA of the knee or hip was determined at the Baseline Visit, if the

Patient's Assessment of Arthritis Pain was at least 40 mm VAS, Patient's and the Physician's Global Assessment of Arthritis was "poor" or "very poor"

Exclusion Criteria:

- Use of NSAIDs or analgesics within 2 days (within 4 days for subjects taking

oxaprozin, piroxicam or full dose aspirin) before baseline arthritis assessments

Pfizer Investigational Site, Kaohsiung, Taiwan

Pfizer Investigational Site, Taipei, Taiwan

Pfizer Investigational Site, Taichung, Taiwan

Pfizer Investigational Site, Kweishan, Taoyuan, Taiwan

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

Link to ClinicalStudyResults.org posting:

Starting date: July 2003
Ending date: April 2004
Last updated: April 7, 2008