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

This study has been completed.
Information provided by:
Pfizer Identifier:
First received: April 1, 2008
Last updated: May 29, 2008
Last verified: April 2008
To study Celebrex versus naproxen to see if it decreases symptoms of juvenile arthritis such as pain and swelling.

Condition Intervention Phase
Arthritis, Juvenile Rheumatoid
Drug: Celecoxib
Drug: Naproxen
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • ACR Pediatric 30 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Peds QOL [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • composites of acr 30 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 225
Study Start Date: October 2002
Study Completion Date: April 2005
Primary Completion Date: April 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High Dose Drug: Celecoxib
Higher dose, 6 mg/kg/dose BID
Experimental: Low Dose Drug: Celecoxib
Active drug at lower dose
Active Comparator: Naproxen
Control comparator, 15 mg/kg/dy target dose
Drug: Naproxen
Control comparator, 15 mg/kg/dy target dose


Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

2-18 years old with active JRA

Exclusion Criteria:

other experimental meds, recent changes in arthritis meds

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00652925

  Show 58 Study Locations
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Identifier: NCT00652925     History of Changes
Other Study ID Numbers: N49-01-02-195  A3191127 
Study First Received: April 1, 2008
Last Updated: May 29, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:

Additional relevant MeSH terms:
Arthritis, Juvenile
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gout Suppressants processed this record on October 21, 2016