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

Verified by: Pfizer, April 2008
First Received: April 1, 2008 | Last Updated: May 29, 2008 | Phase: Phase 3 | Start Date: October 2002
Overall Status: Completed | Estimated Enrollment: 225
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To study Celebrex versus naproxen to see if it decreases symptoms of juvenile arthritis such as pain and swelling...

Brief Summary

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”

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

  • 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
  • Study Primary Completion Date: April 2004

Intervention(s) in this Clinical Trial

  • Drug: Celecoxib
    • Higher dose, 6 mg/kg/dose BID
  • Drug: Celecoxib
    • Active drug at lower dose
  • Drug: Naproxen
    • Control comparator, 15 mg/kg/dy target dose

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: High Dose
  • Experimental: Low Dose
  • Active Comparator: Naproxen
    • Control comparator, 15 mg/kg/dy target dose

Outcome Measures for this Clinical Trial

Primary Measures

  • ACR Pediatric 30
    • Time Frame: 12 weeks
      Safety Issue?: No

Secondary Measures

  • Peds QOL
    • Time Frame: 12 weeks
      Safety Issue?: No
  • composites of acr 30
    • Time Frame: 12 weeks
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • 2-18 years old with active JRA

Exclusion Criteria:

  • other experimental meds, recent changes in arthritis meds

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 2 Years

Maximum Age for this Clinical Trial: 18 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Pfizer Industry

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00652925

Study ID Number: N49-01-02-195

ClinicalTrials.gov Identifier: NCT00652925

Health Authority: United States: Food and Drug Administration

To obtain contact information for a study center near you, click here.

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http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00652925