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

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00648258

Collaborator

(none)

130

Enrollment

Locations

Arms

Duration (Months)

32.5

Patients Per Site

3.6

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Osteoarthritis	Drug: valdecoxib Drug: naproxen	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

130 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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 Start Date :

Jul 1, 2003

Actual Study Completion Date :

Apr 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Arm 1	Drug: valdecoxib valdecoxib 10 mg tablet by mouth once daily for 6 weeks
Active Comparator: Arm 2	Drug: naproxen naproxen 500 mg capsule by mouth twice daily for 6 weeks

Arm

Intervention/Treatment

Active Comparator: Arm 1

Drug: valdecoxib

valdecoxib 10 mg tablet by mouth once daily for 6 weeks

Active Comparator: Arm 2

Drug: naproxen

naproxen 500 mg capsule by mouth twice daily for 6 weeks

Outcome Measures

Primary Outcome Measures

Patient's Assessment of Arthritis Pain (Osteoarthritis-Pain VAS) [Week 6]

Secondary Outcome Measures

Western Ontario and McMaster Universities Osteoarthritis (WOMAC OA) Composite Index [Week 2 and Week 6]
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]
Patient's Assessment of Arthritis Pain (Osteoarthritis-Pain VAS) [Week 2]
Patient's Global Assessment of Arthritis [Week 2 and Week 6]
Physician's Global Assessment of Arthritis [Week 2 and Week 6]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country
1	Pfizer Investigational Site	Kweishan	Taoyuan	Taiwan
2	Pfizer Investigational Site	Kaohsiung		Taiwan
3	Pfizer Investigational Site	Taichung		Taiwan
4	Pfizer Investigational Site	Taipei		Taiwan