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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

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ClinicalTrials.gov Identifier: NCT00652808
Recruitment Status : Completed
First Posted : April 4, 2008
Last Update Posted : April 10, 2008
Sponsor:
Information provided by:
Pfizer

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
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 2004
Actual Study Completion Date : September 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arms and Interventions
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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
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Primary Outcome Measures :
  1. Patient's Assessment of Arthritis Pain using a Visual Analogue Scale (OA-Pain VAS) [ Time Frame: Week 6 ]

Secondary Outcome Measures :
  1. WOMAC OA Physical Function [ Time Frame: Week 2 and Week 6 ]
  2. WOMAC OA Stiffness Index [ Time Frame: Week 2 and Week 6 ]
  3. Patient's Assessment of Arthritis Pain using a Visual Analogue Scale (OA-Pain VAS) [ Time Frame: Week 2 ]
  4. Patient's Global Assessment of Arthritis Pain using a Visual Analogue Scale (OA-Pain VAS) [ Time Frame: Week 2 and Week 6 ]
  5. adverse events [ Time Frame: Continuous ]
  6. Physician's Global Assessment of Arthritis Pain [ Time Frame: Week 2 and Week 6 ]
  7. WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) Osteoarthritis (OA) Composite Index [ Time Frame: Week 2 and Week 6 ]
  8. WOMAC OA Pain Index [ Time Frame: Week 2 and Week 6 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00652808


Locations
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Korea, Republic of
Pfizer Investigational Site
Anyang, Korea, Republic of, 431-070
Pfizer Investigational Site
Gwangju, Korea, Republic of, 501-757
Pfizer Investigational Site
Incheon, Korea, Republic of, 405-760
Pfizer Investigational Site
Pusan, Korea, Republic of, 602-739
Pfizer Investigational Site
Seoul, Korea, Republic of, 110-744
Pfizer Investigational Site
Seoul, Korea, Republic of, 137-701
Pfizer Investigational Site
Seoul, Korea, Republic of, 138-736
Pfizer Investigational Site
Seoul, Korea, Republic of, 152-703
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00652808    
Other Study ID Numbers: A3471045
First Posted: April 4, 2008    Key Record Dates
Last Update Posted: April 10, 2008
Last Verified: April 2008
Keywords provided by Pfizer:
knee, OA patients
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Naproxen
Valdecoxib
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase 2 Inhibitors