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

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00652925

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
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:

MedlinePlus related topics: Juvenile Rheumatoid Arthritis

Drug Information available for: Naproxen Naproxen sodium Celecoxib

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
High Dose: Experimental	Drug: Celecoxib Higher dose, 6 mg/kg/dose BID
Low Dose: Experimental	Drug: Celecoxib Active drug at lower dose
Naproxen: Active Comparator 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

Link to ClinicalStudyResults.org posting: This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	N49-01-02-195, A3191127
Study First Received:	April 1, 2008
Last Updated:	May 29, 2008
ClinicalTrials.gov Identifier:	NCT00652925 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

arthritis
juvenile

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Arthritis, Rheumatoid
Gout Suppressants
Musculoskeletal Diseases
Sensory System Agents
Arthritis
Therapeutic Uses
Connective Tissue Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Celecoxib

Naproxen
Autoimmune Diseases
Arthritis, Juvenile Rheumatoid
Immune System Diseases
Joint Diseases
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Rheumatic Diseases
Pharmacologic Actions
Analgesics, Non-Narcotic
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010