A Study to Evaluate the Efficacy and Safety of Celecoxib Suspension Compared to Naproxen Suspension in Patients With JRA

Condition(s) targeted: Arthritis, Juvenile Rheumatoid

Intervention: Celecoxib (Drug); Celecoxib (Drug); Naproxen (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

To study Celebrex versus naproxen to see if it decreases symptoms of juvenile arthritis such as pain and swelling.

Official title: 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

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study

Primary outcome: ACR Pediatric 30

Secondary outcome:

Peds QOL

composites of acr 30

Minimum age: 2 Years. Maximum age: 18 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

2-18 years old with active JRA

Exclusion Criteria:

other experimental meds, recent changes in arthritis meds

Pfizer Investigational Site, Leuven 3000, Belgium

Pfizer Investigational Site, Rio de Janeiro 21944-970, Brazil

Pfizer Investigational Site, Århus N 8200, Denmark

Pfizer Investigational Site, VANDOEUVRE-LES-NANCY 54511, France

Pfizer Investigational Site, Hamburg 22081, Germany

Pfizer Investigational Site, Halle 06120, Germany

Pfizer Investigational Site, Hannover 30625, Germany

Pfizer Investigational Site, Bremen 28205, Germany

Pfizer Investigational Site, Berlin 13125, Germany

Pfizer Investigational Site, Guadalajara 44650, Mexico

Pfizer Investigational Site, Lima L31, Peru

Pfizer Investigational Site, Lima L05, Peru

Pfizer Investigational Site, Lima L13, Peru

Pfizer Investigational Site, Vila Nova de Famalicao 4764-901, Portugal

Pfizer Investigational Site, Moscow 119296, Russian Federation

Pfizer Investigational Site, Moscow 115522, Russian Federation

Pfizer Investigational Site, Piestany 921 01, Slovakia

Pfizer Investigational Site, Ljubljana 1525, Slovenia

Pfizer Investigational Site, Madrid 28034, Spain

Pfizer Investigational Site, Madrid 28009, Spain

Pfizer Investigational Site, Valencia 46009, Spain

Pfizer Investigational Site, Stockholm SE-17176, Sweden

Pfizer Investigational Site, San Diego, California 92123, United States

Pfizer Investigational Site, Hartford, Connecticut 06106, United States

Pfizer Investigational Site, Miami, Florida 33155, United States

Pfizer Investigational Site, St. Petersburg, Florida 33701, United States

Pfizer Investigational Site, Delray Beach, Florida 33484, United States

Pfizer Investigational Site, Chicago, Illinois 60637, United States

Pfizer Investigational Site, Chicago, Illinois 60649, United States

Pfizer Investigational Site, Glenview, Illinois 60025, United States

Pfizer Investigational Site, Hinsdale, Illinois 60521, United States

Pfizer Investigational Site, Chicago, Illinois 60614, United States

Pfizer Investigational Site, Merrillville, Indiana 46410, United States

Pfizer Investigational Site, New Orleans, Louisiana 70118, United States

Pfizer Investigational Site, Worcester, Massachusetts 01610, United States

Pfizer Investigational Site, Boston, Massachusetts 02115, United States

Pfizer Investigational Site, Omaha, Nebraska 68178, United States

Pfizer Investigational Site, Livingston, New Jersey 07039, United States

Pfizer Investigational Site, New Hyde Park, New York 11040, United States

Pfizer Investigational Site, New York, New York 10032, United States

Pfizer Investigational Site, Monterrey, Nuevo Leon 64460, Mexico

Pfizer Investigational Site, Tulsa, Oklahoma 74133, United States

Pfizer Investigational Site, Tulsa, Oklahoma 74135, United States

Pfizer Investigational Site, Portland, Oregon 97210, United States

Pfizer Investigational Site, Portland, Oregon 97227-1623, United States

Pfizer Investigational Site, Portland, Oregon 97232, United States

Pfizer Investigational Site, Altoona, Pennsylvania 16601, United States

Pfizer Investigational Site, Altoona, Pennsylvania 16602, United States

Pfizer Investigational Site, Duncansville, Pennsylvania 16635, United States

Pfizer Investigational Site, JOHNSTOWN, Pennsylvania 15904, United States

Pfizer Investigational Site, Hershey, Pennsylvania 17033, United States

Pfizer Investigational Site, Lancaster, Pennsylvania 17604, United States

Pfizer Investigational Site, Rio De Janeiro, RJ 20551-030, Brazil

Pfizer Investigational Site, São Paulo, SP 05403-901, Brazil

Pfizer Investigational Site, São Paulo, SP 04025-002, Brazil

Pfizer Investigational Site, Saskatoon, Saskatchewan, Canada

Pfizer Investigational Site, Milwaukee, Wisconsin 53201, United States

Pfizer Investigational Site, Milwaukee, Wisconsin 53226-0509, United States

To obtain contact information for a study center near you, click here.

Link to ClinicalStudyResults.org posting:

Starting date: October 2002
Ending date: April 2005
Last updated: May 29, 2008