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

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00652808

Collaborator

(none)

265

Enrollment

Locations

Arms

Duration (Months)

33.1

Patients Per Site

8.2

Patients Per Site Per Month

Study Details

Study Description

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.

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

Study Design

Study Type:

Interventional

Actual Enrollment :

265 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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 Start Date :

May 1, 2004

Actual Study Completion Date :

Sep 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 using a Visual Analogue Scale (OA-Pain VAS) [Week 6]

Secondary Outcome Measures

WOMAC OA Physical Function [Week 2 and Week 6]
WOMAC OA Stiffness Index [Week 2 and Week 6]
Patient's Assessment of Arthritis Pain using a Visual Analogue Scale (OA-Pain VAS) [Week 2]
Patient's Global Assessment of Arthritis Pain using a Visual Analogue Scale (OA-Pain VAS) [Week 2 and Week 6]
adverse events [Continuous]
Physician's Global Assessment of Arthritis Pain [Week 2 and Week 6]
WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) Osteoarthritis (OA) Composite Index [Week 2 and Week 6]
WOMAC OA Pain Index [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:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Pfizer Investigational Site	Anyang	Korea, Republic of	431-070
2	Pfizer Investigational Site	Gwangju	Korea, Republic of	501-757
3	Pfizer Investigational Site	Incheon	Korea, Republic of	405-760
4	Pfizer Investigational Site	Pusan	Korea, Republic of	602-739
5	Pfizer Investigational Site	Seoul	Korea, Republic of	110-744
6	Pfizer Investigational Site	Seoul	Korea, Republic of	137-701
7	Pfizer Investigational Site	Seoul	Korea, Republic of	138-736
8	Pfizer Investigational Site	Seoul	Korea, Republic of	152-703