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

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.
 
ClinicalTrials.gov Identifier: NCT00652925
Recruitment Status : Completed
First Posted : April 4, 2008
Last Update Posted : May 30, 2008
Sponsor:
Information provided by:
Pfizer

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

Condition or disease Intervention/treatment Phase
Arthritis, Juvenile Rheumatoid Drug: Celecoxib Drug: Naproxen Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 225 participants
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
Study Start Date : October 2002
Actual Primary Completion Date : April 2004
Actual Study Completion Date : April 2005

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. ACR Pediatric 30 [ Time Frame: 12 weeks ]

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

Eligibility Criteria
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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
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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


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

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Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer
ClinicalTrials.gov Identifier: NCT00652925    
Other Study ID Numbers: N49-01-02-195
A3191127
First Posted: April 4, 2008    Key Record Dates
Last Update Posted: May 30, 2008
Last Verified: April 2008
Keywords provided by Pfizer:
arthritis
juvenile
Additional relevant MeSH terms:
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Arthritis
Arthritis, Juvenile
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Celecoxib
Naproxen
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
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Gout Suppressants