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

April 7, 2008 updated by: Pfizer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

265

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • 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, 138-736
        • 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, 152-703
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm 2
Drug: naproxen
naproxen 500 mg capsule by mouth twice daily for 6 weeks
Active Comparator: Arm 1
Drug: valdecoxib
valdecoxib 10 mg tablet by mouth once daily for 6 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Patient's Assessment of Arthritis Pain using a Visual Analogue Scale (OA-Pain VAS)
Time Frame: Week 6
Week 6

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Study Completion (Actual)

September 1, 2004

Study Registration Dates

First Submitted

April 1, 2008

First Submitted That Met QC Criteria

April 3, 2008

First Posted (Estimate)

April 4, 2008

Study Record Updates

Last Update Posted (Estimate)

April 10, 2008

Last Update Submitted That Met QC Criteria

April 7, 2008

Last Verified

April 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A3471045

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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