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

Phase 3CompletedNCT00652925

Pfizer225 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

225

Conditions

Arthritis, Juvenile Rheumatoid

Interventions

CelecoxibDRUG

Higher dose, 6 mg/kg/dose BID

CelecoxibDRUG

Active drug at lower dose

NaproxenDRUG

Control comparator, 15 mg/kg/dy target dose

Eligibility

Sex: ALLMin age: 2 YearsMax age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 2-18 years old with active JRA Exclusion Criteria: other experimental meds, recent changes in arthritis meds

Locations (58)

Outcomes

Primary Outcomes

ACR Pediatric 30

Time frame: 12 weeks

Secondary Outcomes

Peds QOL

Time frame: 12 weeks

composites of acr 30

Time frame: 12 weeks

Data from ClinicalTrials.gov

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Pfizer Investigational Site

San Diego, California, United States

Pfizer Investigational Site

Hartford, Connecticut, United States

Pfizer Investigational Site

Delray Beach, Florida, United States

Pfizer Investigational Site

Miami, Florida, United States

Pfizer Investigational Site

St. Petersburg, Florida, United States

Pfizer Investigational Site

Chicago, Illinois, United States

Pfizer Investigational Site

Chicago, Illinois, United States

Pfizer Investigational Site

Chicago, Illinois, United States

Pfizer Investigational Site

Glenview, Illinois, United States

Pfizer Investigational Site

Hinsdale, Illinois, United States

...and 48 more locations