- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00650455
Efficacy and Safety of Valdecoxib and Naproxen in Treating the Signs and Symptoms of Rheumatoid Arthritis (RA) in a Severe Rheumatoid Arthritis Patients
July 18, 2008 updated by: Pfizer
Clinical Protocol for a Multicenter, Double-Blind, Randomized, Placebo Controlled, Comparison of the Efficacy and Safety of Bextra® (Valdecoxib) 10 mg Once Daily and Naproxen 500 mg Twice Daily in Treating the Signs and Symptoms of Rheumatoid Arthritis (RA) in a Severe RA Population
The objectives of the study were to evaluate the efficacy, safety, and tolerability of valdecoxib 10 mg once daily (QD) or naproxen 500 mg twice daily (BID) versus placebo, and to assess the efficacy of valdecoxib 10 mg QD versus naproxen 500 mg BID, in treating the signs and symptoms of rheumatoid arthritis (RA) in a severe Rheumatoid Arthritis population.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
489
Phase
- Phase 4
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
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Manitoba
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Winnipeg, Manitoba, Canada, R3A 1M1
- Pfizer Investigational Site
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Ontario
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Windsor, Ontario, Canada, N8W 5L7
- Pfizer Investigational Site
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Saskatchewan
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Saskatoon, Saskatchewan, Canada, S7K 0H6
- Pfizer Investigational Site
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Alabama
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Birmingham, Alabama, United States, 35249-7201
- Pfizer Investigational Site
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Huntsville, Alabama, United States, 35801
- Pfizer Investigational Site
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Arizona
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Glendale, Arizona, United States, 85308
- Pfizer Investigational Site
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Glendale, Arizona, United States, 85304
- Pfizer Investigational Site
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Mesa, Arizona, United States, 85202
- Pfizer Investigational Site
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Paradise Valley, Arizona, United States, 85253
- Pfizer Investigational Site
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Phoenix, Arizona, United States, 85012
- Pfizer Investigational Site
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Scottsdale, Arizona, United States, 95260
- Pfizer Investigational Site
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Tucson, Arizona, United States, 85719
- Pfizer Investigational Site
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California
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Fullerton, California, United States, 92835
- Pfizer Investigational Site
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Rancho Mirage, California, United States, 92270
- Pfizer Investigational Site
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San Diego, California, United States, 92120
- Pfizer Investigational Site
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Florida
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Fort Lauderdale, Florida, United States, 33334
- Pfizer Investigational Site
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Jacksonville, Florida, United States, 32204
- Pfizer Investigational Site
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Jupiter, Florida, United States, 33458
- Pfizer Investigational Site
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Ocala, Florida, United States, 34474
- Pfizer Investigational Site
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Orlando, Florida, United States, 32804
- Pfizer Investigational Site
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Palm Harbor, Florida, United States, 34684
- Pfizer Investigational Site
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Tampa, Florida, United States, 33614
- Pfizer Investigational Site
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West Palm Beach, Florida, United States, 33401
- Pfizer Investigational Site
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Zephyrhills, Florida, United States, 33540
- Pfizer Investigational Site
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Idaho
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Idaho Falls, Idaho, United States, 83404
- Pfizer Investigational Site
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Illinois
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Chicago, Illinois, United States, 60612
- Pfizer Investigational Site
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Springfield, Illinois, United States, 62704
- Pfizer Investigational Site
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Indiana
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Indianapolis, Indiana, United States, 46227
- Pfizer Investigational Site
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Maryland
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Frederick, Maryland, United States, 21702
- Pfizer Investigational Site
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Greenbelt, Maryland, United States, 20770
- Pfizer Investigational Site
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Michigan
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Lansing, Michigan, United States, 48910
- Pfizer Investigational Site
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Mississippi
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Jackson, Mississippi, United States, 39216
- Pfizer Investigational Site
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New Jersey
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Marlton, New Jersey, United States, 8053
- Pfizer Investigational Site
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Passaic, New Jersey, United States, 07055
- Pfizer Investigational Site
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Teaneck, New Jersey, United States, 07666
- Pfizer Investigational Site
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New York
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Brooklyn, New York, United States, 11203
- Pfizer Investigational Site
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New York, New York, United States, 10021
- Pfizer Investigational Site
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New York, New York, United States, 10035
- Pfizer Investigational Site
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Ohio
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Columbus, Ohio, United States, 43214
- Pfizer Investigational Site
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Pennsylvania
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Allentown, Pennsylvania, United States, 18103
- Pfizer Investigational Site
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Duncansville, Pennsylvania, United States, 16635
- Pfizer Investigational Site
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Erie, Pennsylvania, United States, 16508
- Pfizer Investigational Site
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Johnstown, Pennsylvania, United States, 15904
- Pfizer Investigational Site
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Mechanicsburg, Pennsylvania, United States, 17055
- Pfizer Investigational Site
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Philadelphia, Pennsylvania, United States, 19102
- Pfizer Investigational Site
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Philadephia, Pennsylvania, United States, 19152
- Pfizer Investigational Site
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Rhode Island
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Providence, Rhode Island, United States, 02906
- Pfizer Investigational Site
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Texas
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Dallas, Texas, United States, 75246
- Pfizer Investigational Site
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El Paso, Texas, United States, 79902
- Pfizer Investigational Site
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Fort Worth, Texas, United States, 76107
- Pfizer Investigational Site
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Plano, Texas, United States, 75093
- Pfizer Investigational Site
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San Antonio, Texas, United States, 78240
- Pfizer Investigational Site
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San Antonio, Texas, United States, 78232
- Pfizer Investigational Site
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Virginia
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Arlington, Virginia, United States, 22204
- Pfizer Investigational Site
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Washington
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Seattle, Washington, United States, 98166-2967
- Pfizer Investigational Site
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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:
- A diagnosis of severe rheumatoid arthritis (RA) for at least 6 months
- The Rheumatoid Arthritis must have been treated with a stable regimen including a non-steroidal anti-inflammatory drug (NSAID), as well as methotrexate for at least 12 weeks -OR- an NSAID (for at least 12 weeks plus a tumor necrosis factor inhibitor (i.e., adalimumab [Humira®] for a minimum of 5 doses on a regular schedule, etanercept [Enbrel®] for 6 weeks, infliximab (Remicade®) for 3 doses and currently on a stable regimen of infusions not more than every 8 weeks)
Exclusion Criteria:
- A diagnosis of any other inflammatory arthritis or a secondary, noninflammatory type of arthritis (eg, osteoarthritis (OA) or fibromyalgia) that, in the investigator's opinion, was symptomatic enough to interfere with the evaluation of the effect of valdecoxib on the patient's primary diagnosis of Rheumatoid Arthritis were excluded from the study
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
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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ACTIVE_COMPARATOR: Arm 2
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naproxen 500 mg capsule twice daily for 12 weeks
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ACTIVE_COMPARATOR: Arm 1
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valdecoxib 10 mg tablet once daily for 12 weeks
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PLACEBO_COMPARATOR: Arm 3
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placebo tablet every morning and capsule every evening for 12 weeks
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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ACR-20 criteria responder
Time Frame: Week 12
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Week 12
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Patient's Global Assessment of Disease Activity
Time Frame: Screening, Baseline, Week 1, Week 6, and Week 12
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Screening, Baseline, Week 1, Week 6, and Week 12
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Duration of morning stiffness
Time Frame: Screening, Baseline, Week 1, Week 6, and Week 12
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Screening, Baseline, Week 1, Week 6, and Week 12
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Incidence and time to withdrawal due to insufficient clinical response
Time Frame: Study endpoint
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Study endpoint
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Physician's Global Assessment of Disease Activity
Time Frame: Screening, Baseline, Week 1, Week 6, and Week 12
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Screening, Baseline, Week 1, Week 6, and Week 12
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swollen joint count
Time Frame: Screening, Baseline, Week 1, Week 6, and Week 12
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Screening, Baseline, Week 1, Week 6, and Week 12
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Adverse events
Time Frame: Baseline, Week 1, Week 6, and Week 12
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Baseline, Week 1, Week 6, and Week 12
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Average rescue medication usage per day
Time Frame: Study endpoint
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Study endpoint
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Short Form-36 Acute Health Survey
Time Frame: Baseline, Week 1, Week 6, and Week 12
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Baseline, Week 1, Week 6, and Week 12
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tender joint count
Time Frame: Screening, Baseline, Week 1, Week 6, and Week 12
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Screening, Baseline, Week 1, Week 6, and Week 12
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One-Week Severity of Dyspepsia Assessment
Time Frame: Baseline, Week 1, and Week 12
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Baseline, Week 1, and Week 12
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C-reactive protein
Time Frame: Screening, Baseline, Week 1, Week 6, and Week 12
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Screening, Baseline, Week 1, Week 6, and Week 12
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laboratory tests
Time Frame: Screening, Baseline, Week 1, Week 6, and Week 12
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Screening, Baseline, Week 1, Week 6, and Week 12
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vital signs
Time Frame: Screening, Baseline, Week 1, Week 6, and Week 12
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Screening, Baseline, Week 1, Week 6, and Week 12
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physical examinations
Time Frame: Screening and Week 12
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Screening and Week 12
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ACR-N
Time Frame: Study endpoint
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Study endpoint
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Patient Treatment Satisfaction Scale
Time Frame: Week 1 and Week 6
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Week 1 and Week 6
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Patient's assessment of arthritis pain (VAS)
Time Frame: Screening, Baseline, Week 1, Week 6, and Week 12
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Screening, Baseline, Week 1, Week 6, and Week 12
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Health Assessment Questionnaire (HAQ) Disability Index
Time Frame: Screening, Baseline, Week 1, Week 6, and Week 12
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Screening, Baseline, Week 1, Week 6, and Week 12
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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.
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
February 1, 2003
Primary Completion (ACTUAL)
January 1, 2005
Study Completion (ACTUAL)
January 1, 2005
Study Registration Dates
First Submitted
March 28, 2008
First Submitted That Met QC Criteria
March 28, 2008
First Posted (ESTIMATE)
April 1, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
July 21, 2008
Last Update Submitted That Met QC Criteria
July 18, 2008
Last Verified
July 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Autoimmune Diseases
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Connective Tissue Diseases
- Arthritis
- Arthritis, Rheumatoid
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Cyclooxygenase 2 Inhibitors
- Gout Suppressants
- Naproxen
- Valdecoxib
Other Study ID Numbers
- A3471018
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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