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

Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00652808
• Other study ID #: A3471045
• Status: Completed
• Phase: Phase 3
• First received: April 1, 2008
• Last updated: April 7, 2008
• Start date: May 2004
• Est. completion date: September 2004

Study information

• Verified date: April 2008
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unkown: Obtaining information and will provide once confirmed.
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 265
• Est. completion date: September 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee
• 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
Korea, Republic of	Pfizer Investigational Site	Anyang
Korea, Republic of	Pfizer Investigational Site	Gwangju
Korea, Republic of	Pfizer Investigational Site	Incheon
Korea, Republic of	Pfizer Investigational Site	Pusan
Korea, Republic of	Pfizer Investigational Site	Seoul
Korea, Republic of	Pfizer Investigational Site	Seoul
Korea, Republic of	Pfizer Investigational Site	Seoul
Korea, Republic of	Pfizer Investigational Site	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient's Assessment of Arthritis Pain using a Visual Analogue Scale (OA-Pain VAS)		Week 6	No
Secondary	WOMAC OA Physical Function		Week 2 and Week 6	No
Secondary	WOMAC OA Stiffness Index		Week 2 and Week 6	No
Secondary	Patient's Assessment of Arthritis Pain using a Visual Analogue Scale (OA-Pain VAS)		Week 2	No
Secondary	Patient's Global Assessment of Arthritis Pain using a Visual Analogue Scale (OA-Pain VAS)		Week 2 and Week 6	No
Secondary	adverse events		Continuous	Yes
Secondary	Physician's Global Assessment of Arthritis Pain		Week 2 and Week 6	No
Secondary	WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) Osteoarthritis (OA) Composite Index		Week 2 and Week 6	No
Secondary	WOMAC OA Pain Index		Week 2 and Week 6	No

External Links

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