- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00652925
A Study to Evaluate the Efficacy and Safety of Celecoxib Suspension Compared to Naproxen Suspension in Patients With JRA
May 29, 2008 updated by: Pfizer
Randomized, Double-Blind, Multicenter, Active Controlled Parallel Group Study to Evaluate the Efficacy and Safety of Celecoxib Suspension Compared to Naproxen Suspension in Patients With JRA
To study Celebrex versus naproxen to see if it decreases symptoms of juvenile arthritis such as pain and swelling.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
225
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
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Leuven, Belgium, 3000
- Pfizer Investigational Site
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Rio de Janeiro, Brazil, 21944-970
- Pfizer Investigational Site
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RJ
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Rio De Janeiro, RJ, Brazil, 20551-030
- Pfizer Investigational Site
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SP
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São Paulo, SP, Brazil, 04025-002
- Pfizer Investigational Site
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São Paulo, SP, Brazil, 05403-901
- Pfizer Investigational Site
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Saskatchewan
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Saskatoon, Saskatchewan, Canada
- Pfizer Investigational Site
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Århus N, Denmark, 8200
- Pfizer Investigational Site
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Vandoeuvre-les-nancy, France, 54511
- Pfizer Investigational Site
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Berlin, Germany, 13125
- Pfizer Investigational Site
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Bremen, Germany, 28205
- Pfizer Investigational Site
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Halle, Germany, 06120
- Pfizer Investigational Site
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Hamburg, Germany, 22081
- Pfizer Investigational Site
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Hannover, Germany, 30625
- Pfizer Investigational Site
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Guadalajara, Mexico, 44650
- Pfizer Investigational Site
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Nuevo Leon
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Monterrey, Nuevo Leon, Mexico, 64460
- Pfizer Investigational Site
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Lima, Peru, L13
- Pfizer Investigational Site
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Lima, Peru, L05
- Pfizer Investigational Site
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Lima, Peru, L31
- Pfizer Investigational Site
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Vila Nova de Famalicao, Portugal, 4764-901
- Pfizer Investigational Site
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Moscow, Russian Federation, 115522
- Pfizer Investigational Site
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Moscow, Russian Federation, 119296
- Pfizer Investigational Site
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Piestany, Slovakia, 921 01
- Pfizer Investigational Site
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Ljubljana, Slovenia, 1525
- Pfizer Investigational Site
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Madrid, Spain, 28034
- Pfizer Investigational Site
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Madrid, Spain, 28009
- Pfizer Investigational Site
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Valencia, Spain, 46009
- Pfizer Investigational Site
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Stockholm, Sweden, SE-17176
- Pfizer Investigational Site
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California
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San Diego, California, United States, 92123
- Pfizer Investigational Site
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Connecticut
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Hartford, Connecticut, United States, 06106
- Pfizer Investigational Site
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Florida
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Delray Beach, Florida, United States, 33484
- Pfizer Investigational Site
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Miami, Florida, United States, 33155
- Pfizer Investigational Site
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St. Petersburg, Florida, United States, 33701
- Pfizer Investigational Site
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Illinois
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Chicago, Illinois, United States, 60637
- Pfizer Investigational Site
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Chicago, Illinois, United States, 60614
- Pfizer Investigational Site
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Chicago, Illinois, United States, 60649
- Pfizer Investigational Site
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Glenview, Illinois, United States, 60025
- Pfizer Investigational Site
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Hinsdale, Illinois, United States, 60521
- Pfizer Investigational Site
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Indiana
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Merrillville, Indiana, United States, 46410
- Pfizer Investigational Site
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Louisiana
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New Orleans, Louisiana, United States, 70118
- Pfizer Investigational Site
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Massachusetts
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Boston, Massachusetts, United States, 02115
- Pfizer Investigational Site
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Worcester, Massachusetts, United States, 01610
- Pfizer Investigational Site
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Nebraska
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Omaha, Nebraska, United States, 68178
- Pfizer Investigational Site
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New Jersey
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Livingston, New Jersey, United States, 07039
- Pfizer Investigational Site
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New York
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New Hyde Park, New York, United States, 11040
- Pfizer Investigational Site
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New York, New York, United States, 10032
- Pfizer Investigational Site
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Oklahoma
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Tulsa, Oklahoma, United States, 74133
- Pfizer Investigational Site
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Tulsa, Oklahoma, United States, 74135
- Pfizer Investigational Site
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Oregon
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Portland, Oregon, United States, 97210
- Pfizer Investigational Site
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Portland, Oregon, United States, 97232
- Pfizer Investigational Site
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Portland, Oregon, United States, 97227-1623
- Pfizer Investigational Site
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Pennsylvania
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Altoona, Pennsylvania, United States, 16602
- Pfizer Investigational Site
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Altoona, Pennsylvania, United States, 16601
- Pfizer Investigational Site
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Duncansville, Pennsylvania, United States, 16635
- Pfizer Investigational Site
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Hershey, Pennsylvania, United States, 17033
- Pfizer Investigational Site
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Johnstown, Pennsylvania, United States, 15904
- Pfizer Investigational Site
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Lancaster, Pennsylvania, United States, 17604
- Pfizer Investigational Site
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Wisconsin
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Milwaukee, Wisconsin, United States, 53201
- Pfizer Investigational Site
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Milwaukee, Wisconsin, United States, 53226-0509
- 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
2 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
2-18 years old with active JRA
Exclusion Criteria:
other experimental meds, recent changes in arthritis meds
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: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: High Dose
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Higher dose, 6 mg/kg/dose BID
Active drug at lower dose
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Experimental: Low Dose
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Higher dose, 6 mg/kg/dose BID
Active drug at lower dose
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Active Comparator: Naproxen
Control comparator, 15 mg/kg/dy target dose
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Control comparator, 15 mg/kg/dy target dose
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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ACR Pediatric 30
Time Frame: 12 weeks
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12 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Peds QOL
Time Frame: 12 weeks
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12 weeks
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composites of acr 30
Time Frame: 12 weeks
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12 weeks
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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
October 1, 2002
Primary Completion (Actual)
April 1, 2004
Study Completion (Actual)
April 1, 2005
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)
May 30, 2008
Last Update Submitted That Met QC Criteria
May 29, 2008
Last Verified
April 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, Juvenile
- 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
- Celecoxib
- Naproxen
Other Study ID Numbers
- N49-01-02-195
- A3191127
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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