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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:
ClinicalTrials.gov Identifier:
NCT00652925
First Posted: April 4, 2008
Last Update Posted: May 30, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pfizer
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]

Secondary Outcome Measures:
  • Peds QOL [ Time Frame: 12 weeks ]
  • composites of acr 30 [ Time Frame: 12 weeks ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00652925


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

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer
ClinicalTrials.gov Identifier: NCT00652925     History of Changes
Other Study ID Numbers: N49-01-02-195
A3191127
First Submitted: April 1, 2008
First Posted: April 4, 2008
Last Update Posted: May 30, 2008
Last Verified: April 2008

Keywords provided by Pfizer:
arthritis
juvenile

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