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

Pfizer logo

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

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

Trial contacts and locations

58

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Data sourced from clinicaltrials.gov

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