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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00652808
First received: April 1, 2008
Last updated: April 7, 2008
Last verified: April 2008
  Purpose

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 Intervention Phase
Osteoarthritis
Knee
Drug: valdecoxib
Drug: naproxen
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Patient's Assessment of Arthritis Pain using a Visual Analogue Scale (OA-Pain VAS) [ Time Frame: Week 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • WOMAC OA Physical Function [ Time Frame: Week 2 and Week 6 ] [ Designated as safety issue: No ]
  • WOMAC OA Stiffness Index [ Time Frame: Week 2 and Week 6 ] [ Designated as safety issue: No ]
  • Patient's Assessment of Arthritis Pain using a Visual Analogue Scale (OA-Pain VAS) [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
  • Patient's Global Assessment of Arthritis Pain using a Visual Analogue Scale (OA-Pain VAS) [ Time Frame: Week 2 and Week 6 ] [ Designated as safety issue: No ]
  • adverse events [ Time Frame: Continuous ] [ Designated as safety issue: Yes ]
  • Physician's Global Assessment of Arthritis Pain [ Time Frame: Week 2 and Week 6 ] [ Designated as safety issue: No ]
  • WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) Osteoarthritis (OA) Composite Index [ Time Frame: Week 2 and Week 6 ] [ Designated as safety issue: No ]
  • WOMAC OA Pain Index [ Time Frame: Week 2 and Week 6 ] [ Designated as safety issue: No ]

Enrollment: 265
Study Start Date: May 2004
Study Completion Date: September 2004
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00652808

Locations
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, 152-703
Pfizer Investigational Site
Seoul, Korea, Republic of, 138-736
Pfizer Investigational Site
Seoul, Korea, Republic of, 137-701
Pfizer Investigational Site
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00652808     History of Changes
Other Study ID Numbers: A3471045
Study First Received: April 1, 2008
Last Updated: April 7, 2008
Health Authority: Unkown: Obtaining information and will provide once confirmed.

Keywords provided by Pfizer:
knee, OA patients

Additional relevant MeSH terms:
Osteoarthritis
Signs and Symptoms
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
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents
Cyclooxygenase 2 Inhibitors

ClinicalTrials.gov processed this record on July 26, 2014