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OpenTrials
Completed

NCT Number: NCT00652925

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

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

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Key information

Conditions

Arthritis, Juvenile Rheumatoid Arthritis Arthritis, Juvenile Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pfizer Investigational Site, Leuven, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

2-18 years old with active JRA

Exclusion criteria

other experimental meds, recent changes in arthritis meds

Treatment and study plan

Celecoxib

Drug

Higher dose, 6 mg/kg/dose BID

Naproxen

Drug

Control comparator, 15 mg/kg/dy target dose

Primary outcomes

  1. ACR Pediatric 30

    Time frame: 12 weeks

Secondary outcomes

  1. Peds QOL

    Time frame: 12 weeks

  2. composites of acr 30

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2002
Primary completion
2004
Study completion
2005
First posted
Apr 4, 2008
Registry last updated
May 30, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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