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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.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00652925
First received: April 1, 2008
Last updated: May 29, 2008
Last verified: April 2008
History of Changes
  Purpose

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:

U.S. FDA Resources

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

  Eligibility

Ages Eligible for Study:   2 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

2-18 years old with active JRA

Exclusion Criteria:

other experimental meds, recent changes in arthritis meds

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00652925

  Show 58 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer
ClinicalTrials.gov 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:
arthritis
juvenile

Additional relevant MeSH terms:
Arthritis
Arthritis, Juvenile Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Arthritis, Rheumatoid
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Naproxen
Celecoxib
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents
Cyclooxygenase 2 Inhibitors

ClinicalTrials.gov processed this record on May 19, 2013