NCT00652925

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 225 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 2 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Arthritis, Juvenile Rheumatoid

Interventions

Type	Name	Description
DRUG	Celecoxib	Higher dose, 6 mg/kg/dose BID
DRUG	Celecoxib	Active drug at lower dose
DRUG	Naproxen	Control comparator, 15 mg/kg/dy target dose

Timeline

• Start date: 2002-10-01
• Primary completion: 2004-04-01
• Completion: 2005-04-01
• First posted: 2008-04-04
• Last updated: 2008-05-30

Locations

58 sites across 15 countries: United States, Belgium, Brazil, Canada, Denmark, France, Germany, Mexico, Peru, Portugal, Russia, Slovakia, Slovenia, Spain, Sweden