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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00652925

Enrollment

225

Registered

2008-04-04

Start date

2002-10-31

Completion date

2005-04-30

Last updated

2008-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthritis, Juvenile Rheumatoid

Keywords

arthritis, juvenile

Brief summary

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

Interventions

DRUGCelecoxib

Higher dose, 6 mg/kg/dose BID

DRUGNaproxen

Control comparator, 15 mg/kg/dy target dose

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

2 Years to 18 Years

Healthy volunteers

Inclusion criteria

2-18 years old with active JRA

Exclusion criteria

other experimental meds, recent changes in arthritis meds

Design outcomes

Primary

Measure	Time frame
ACR Pediatric 30	12 weeks

Secondary

Measure	Time frame
Peds QOL	12 weeks
composites of acr 30	12 weeks

Countries

Belgium, Brazil, Canada, Denmark, France, Germany, Mexico, Peru, Portugal, Russia, Slovakia, Slovenia, Spain, Sweden, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026