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

Pfizer

Status and phase: Completed; Phase 3

Conditions: Arthritis, Juvenile Rheumatoid

Treatments: Drug: Naproxen; Drug: Celecoxib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00652925

A3191127

N49-01-02-195

Details and patient eligibility

About

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

Enrollment: 225 patients

Sex: All

Ages: 2 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

2-18 years old with active JRA

Exclusion criteria

other experimental meds, recent changes in arthritis meds

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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225 participants in 3 patient groups

High Dose

Experimental group

Treatment:

Drug: Celecoxib

Drug: Celecoxib

Low Dose

Experimental group

Treatment:

Drug: Celecoxib

Drug: Celecoxib

Naproxen

Active Comparator group

Description:

Control comparator, 15 mg/kg/dy target dose

Treatment:

Drug: Naproxen