Clinical trial NCT00652808: Double-Blind, Double Dummy, Randomized Comparison Study to Evaluate the Efficacy and Safety of Valdecoxib 10 mg Once Daily and Naproxen 500 mg Twice Daily in Treating the Signs and Symptoms of Osteoarthritis of the Knee
Official title: Double-Blind, Double Dummy, Randomized Comparison Study to Evaluate the Efficacy and Safety of Valdecoxib 10 mg QD and Naproxen 500 mg BID in Treating the Signs and Symptoms of Osteoarthritis of the Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis
Knee
Keywords: knee, OA patients
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-04-04
Enrollment: 265
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: This study was performed to demonstrate that treatment with valdecoxib 10 mg daily (QD) was at least as effective as with naproxen 500 mg twice daily (BID), a standard non-steroidal anti-inflammatory drug (NSAID), when taken for 6 weeks in Korean subjects with symptomatic osteoarthritis (OA) of the knee. Secondary objectives were to assess the overall safety and tolerability of valdecoxib 10 mg QD taken for 6 weeks in Korean subjects with symptomatic OA of the knee.


Eligibility criteria: Inclusion Criteria:

* Korean outpatients with symptomatic radiologic evidence of OA of the knee (diagnosed according to the modified American College Rheumatology criteria)
* Patient's Assessment of Arthritis Pain measurement of at least 40 mm on VAS
* Patients had not received any NSAIDs or analgesics within 2 days (within 4 days for subjects taking oxaprozin, piroxicam or full dose aspirin) prior to the Baseline Visit

Exclusion Criteria:

* Diagnosis of inflammatory arthritis, gout, pseudogout, Paget's disease, or any chronic pain syndrome that, in the Investigator's opinion, would interfere with the assessment of the Index Knee
* Symptomatic anserine bursitis or acute joint trauma of the Index Knee
* Arthroscopy performed on the Index Knee within the past 12 months
* Complete loss of articular cartilage of the Index Knee
* Administration of oral, or intramuscular, intravenous, or soft tissue injections of corticosterosteroids within 4 weeks prior to screening visit
* Administration of intra-articular injection of corticosteroids or hyaluronic acid preparation in the Index Knee within 3 months or 6 months, respectively

Primary outcomes:
measure: Patient's Assessment of Arthritis Pain using a Visual Analogue Scale (OA-Pain VAS)
timeFrame: Week 6
Secondary outcomes:
measure: WOMAC OA Physical Function
timeFrame: Week 2 and Week 6
measure: WOMAC OA Stiffness Index
timeFrame: Week 2 and Week 6
measure: Patient's Assessment of Arthritis Pain using a Visual Analogue Scale (OA-Pain VAS)
timeFrame: Week 2
measure: Patient's Global Assessment of Arthritis Pain using a Visual Analogue Scale (OA-Pain VAS)
timeFrame: Week 2 and Week 6
measure: adverse events
timeFrame: Continuous
measure: Physician's Global Assessment of Arthritis Pain
timeFrame: Week 2 and Week 6
measure: WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) Osteoarthritis (OA) Composite Index
timeFrame: Week 2 and Week 6
measure: WOMAC OA Pain Index
timeFrame: Week 2 and Week 6
Other outcomes:
Locations:
city: Anyang
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Gwangju
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Incheon
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Pusan
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: