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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00648258

Enrollment

130

Registered

2008-04-01

Start date

2003-07-31

Completion date

2004-04-30

Last updated

2018-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis

Keywords

osteoarthritis, knee, osteoarthritis, hip

Brief summary

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).

Interventions

DRUGvaldecoxib

valdecoxib 10 mg tablet by mouth once daily for 6 weeks

DRUGnaproxen

naproxen 500 mg capsule by mouth twice daily for 6 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Patient's Assessment of Arthritis Pain (Osteoarthritis-Pain VAS)	Week 6

Secondary

Measure	Time frame
WOMAC OA physical function	Week 2 and Week 6
WOMAC OA pain index	Week 2 and Week 6
WOMAC OA stiffness index	Week 2 and Week 6
Western Ontario and McMaster Universities Osteoarthritis (WOMAC OA) Composite Index	Week 2 and Week 6
Patient's Global Assessment of Arthritis	Week 2 and Week 6
Physician's Global Assessment of Arthritis	Week 2 and Week 6
Patient's Assessment of Arthritis Pain (Osteoarthritis-Pain VAS)	Week 2

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026