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
  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:


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:
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 April 23, 2014