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

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

      • Leuven, Belgium, 3000
        • Pfizer Investigational Site
      • Rio de Janeiro, Brazil, 21944-970
        • Pfizer Investigational Site
    • RJ
      • Rio De Janeiro, RJ, Brazil, 20551-030
        • Pfizer Investigational Site
    • SP
      • São Paulo, SP, Brazil, 04025-002
        • Pfizer Investigational Site
      • São Paulo, SP, Brazil, 05403-901
        • Pfizer Investigational Site
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada
        • Pfizer Investigational Site
      • Århus N, Denmark, 8200
        • Pfizer Investigational Site
      • Vandoeuvre-les-nancy, France, 54511
        • Pfizer Investigational Site
      • Berlin, Germany, 13125
        • Pfizer Investigational Site
      • Bremen, Germany, 28205
        • Pfizer Investigational Site
      • Halle, Germany, 06120
        • Pfizer Investigational Site
      • Hamburg, Germany, 22081
        • Pfizer Investigational Site
      • Hannover, Germany, 30625
        • Pfizer Investigational Site
      • Guadalajara, Mexico, 44650
        • Pfizer Investigational Site
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico, 64460
        • Pfizer Investigational Site
      • Lima, Peru, L13
        • Pfizer Investigational Site
      • Lima, Peru, L05
        • Pfizer Investigational Site
      • Lima, Peru, L31
        • Pfizer Investigational Site
      • Vila Nova de Famalicao, Portugal, 4764-901
        • Pfizer Investigational Site
      • Moscow, Russian Federation, 115522
        • Pfizer Investigational Site
      • Moscow, Russian Federation, 119296
        • Pfizer Investigational Site
      • Piestany, Slovakia, 921 01
        • Pfizer Investigational Site
      • Ljubljana, Slovenia, 1525
        • Pfizer Investigational Site
      • Madrid, Spain, 28034
        • Pfizer Investigational Site
      • Madrid, Spain, 28009
        • Pfizer Investigational Site
      • Valencia, Spain, 46009
        • Pfizer Investigational Site
      • Stockholm, Sweden, SE-17176
        • Pfizer Investigational Site
    • California
      • San Diego, California, United States, 92123
        • Pfizer Investigational Site
    • Connecticut
      • Hartford, Connecticut, United States, 06106
        • Pfizer Investigational Site
    • Florida
      • Delray Beach, Florida, United States, 33484
        • Pfizer Investigational Site
      • Miami, Florida, United States, 33155
        • Pfizer Investigational Site
      • St. Petersburg, Florida, United States, 33701
        • Pfizer Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Pfizer Investigational Site
      • Chicago, Illinois, United States, 60614
        • Pfizer Investigational Site
      • Chicago, Illinois, United States, 60649
        • Pfizer Investigational Site
      • Glenview, Illinois, United States, 60025
        • Pfizer Investigational Site
      • Hinsdale, Illinois, United States, 60521
        • Pfizer Investigational Site
    • Indiana
      • Merrillville, Indiana, United States, 46410
        • Pfizer Investigational Site
    • Louisiana
      • New Orleans, Louisiana, United States, 70118
        • Pfizer Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Pfizer Investigational Site
      • Worcester, Massachusetts, United States, 01610
        • Pfizer Investigational Site
    • Nebraska
      • Omaha, Nebraska, United States, 68178
        • Pfizer Investigational Site
    • New Jersey
      • Livingston, New Jersey, United States, 07039
        • Pfizer Investigational Site
    • New York
      • New Hyde Park, New York, United States, 11040
        • Pfizer Investigational Site
      • New York, New York, United States, 10032
        • Pfizer Investigational Site
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74133
        • Pfizer Investigational Site
      • Tulsa, Oklahoma, United States, 74135
        • Pfizer Investigational Site
    • Oregon
      • Portland, Oregon, United States, 97210
        • Pfizer Investigational Site
      • Portland, Oregon, United States, 97232
        • Pfizer Investigational Site
      • Portland, Oregon, United States, 97227-1623
        • Pfizer Investigational Site
    • Pennsylvania
      • Altoona, Pennsylvania, United States, 16602
        • Pfizer Investigational Site
      • Altoona, Pennsylvania, United States, 16601
        • Pfizer Investigational Site
      • Duncansville, Pennsylvania, United States, 16635
        • Pfizer Investigational Site
      • Hershey, Pennsylvania, United States, 17033
        • Pfizer Investigational Site
      • Johnstown, Pennsylvania, United States, 15904
        • Pfizer Investigational Site
      • Lancaster, Pennsylvania, United States, 17604
        • Pfizer Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53201
        • Pfizer Investigational Site
      • Milwaukee, Wisconsin, United States, 53226-0509
        • 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

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
Experimental: High Dose
Higher dose, 6 mg/kg/dose BID
Active drug at lower dose
Experimental: Low Dose
Higher dose, 6 mg/kg/dose BID
Active drug at lower dose
Active Comparator: Naproxen
Control comparator, 15 mg/kg/dy target dose
Control comparator, 15 mg/kg/dy target dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
ACR Pediatric 30
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Peds QOL
Time Frame: 12 weeks
12 weeks
composites of acr 30
Time Frame: 12 weeks
12 weeks

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

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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