Clinical trial NCT00648258: 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
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis
Keywords: osteoarthritis, knee
osteoarthritis, hip
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-04-01
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility 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

Primary outcomes:
measure: Patient's Assessment of Arthritis Pain (Osteoarthritis-Pain VAS)
timeFrame: Week 6
Secondary outcomes:
measure: Western Ontario and McMaster Universities Osteoarthritis (WOMAC OA) Composite Index
timeFrame: Week 2 and Week 6
measure: WOMAC OA physical function
timeFrame: Week 2 and Week 6
measure: WOMAC OA pain index
timeFrame: Week 2 and Week 6
measure: WOMAC OA stiffness index
timeFrame: Week 2 and Week 6
measure: Patient's Assessment of Arthritis Pain (Osteoarthritis-Pain VAS)
timeFrame: Week 2
measure: Patient's Global Assessment of Arthritis
timeFrame: Week 2 and Week 6
measure: Physician's Global Assessment of Arthritis
timeFrame: Week 2 and Week 6
Other outcomes:
Locations:
city: Kweishan
country: Taiwan
facility: Pfizer Investigational Site
state: Taoyuan
city: Kaohsiung
country: Taiwan
facility: Pfizer Investigational Site
city: Taichung
country: Taiwan
facility: Pfizer Investigational Site
city: Taipei
country: Taiwan
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: