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

Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00648258
• Other study ID #: VALA-0513-141
• Secondary ID: A3471101
• Status: Completed
• Phase: Phase 3
• Start date: July 2003
• Est. completion date: April 2004

Study information

• Verified date: December 2018
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: April 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee
• Signs and Symptoms

Intervention

Drug:
• valdecoxib
valdecoxib 10 mg tablet by mouth once daily for 6 weeks
• naproxen
naproxen 500 mg capsule by mouth twice daily for 6 weeks

Locations

Country	Name	City	State
Taiwan	Pfizer Investigational Site	Kaohsiung
Taiwan	Pfizer Investigational Site	Kweishan	Taoyuan
Taiwan	Pfizer Investigational Site	Taichung
Taiwan	Pfizer Investigational Site	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Taiwan, 

Outcome

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

External Links

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