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

Phase 3

Completed

• Conditions: Arthritis, Juvenile Rheumatoid
• Interventions: Drug: Celecoxib; Drug: Naproxen

• Registration Number: NCT00652925
• Lead Sponsor: Pfizer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2002-10
• Primary Completion: 2004-04
• Study Completion: 2005-04
• Status Verified: 2008-04
• Study First Submitted: 2008-04-01
• Study First Submitted QC: 2008-04-03
• Study First Posted: 2008-04-04
• Last Update Submitted: 2008-05-29
• Last Update Posted: 2008-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 225

Inclusion Criteria

2-18 years old with active JRA

Exclusion Criteria

other experimental meds, recent changes in arthritis meds

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low Dose	Celecoxib	-
Naproxen	Naproxen	Control comparator, 15 mg/kg/dy target dose
High Dose	Celecoxib	-

Primary Outcome Measures

Name	Time	Method
ACR Pediatric 30	12 weeks

Secondary Outcome Measures

Name	Time	Method
Peds QOL	12 weeks
composites of acr 30	12 weeks

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇸🇪 Stockholm, Sweden