A Phase 4, 6-Week, Randomized Double-Blind, Multicenter, Active-Controlled Trial To Evaluate The Effects Of Celecoxib (Celebrex®) Or Naproxen On Blood Pressure In Pediatric Subjects - Full Text View

Sponsor:	Pfizer
Information provided by (Responsible Party):	Pfizer
ClinicalTrials.gov Identifier:	NCT00807846

Purpose

This Is A Multicenter, Active-Controlled Trial To Evaluate The Effects Of Celecoxib (Celebrex®) Or Naproxen On Blood Pressure In Pediatric Subjects With Juvenile Idiopathic Arthritis

Condition	Intervention	Phase
Arthritis, Juvenile Rheumatoid	Drug: Celecoxib Drug: Naproxen	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Phase 4, 6-Week, Randomized Double-Blind, Multicenter, Active-Controlled Trial To Evaluate The Effects Of Celecoxib (Celebrex®) Or Naproxen On Blood Pressure In Pediatric Subjects With Juvenile Idiopathic Arthritis

Resource links provided by NLM:

Genetics Home Reference related topics: juvenile idiopathic arthritis

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:

The primary objective of the study is to evaluate the effect of treatment with celecoxib on systolic BP (SBP) compared to treatment with naproxen in subjects with Juvenile Idiopathic Arthritis [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Effect of treatment with celecoxib on diastolic BP (DBP) compared to treatment with naproxen in subjects with JIA [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
Adverse event profile and GI tolerability of treatment with celecoxib vs. treatment with naproxen in subjects with JIA [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
Effect of treatment with celecoxib on Parent's and Subject's Global Assessment of Overall Well-Being compared to treatment with naproxen in subjects with JIA [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Effect of celecoxib and naproxen on blood pressure measured by Ambulatory Blood Pressure Monitoring (ABPM) in subjects with JIA [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	200
Study Start Date:	September 2009
Estimated Study Completion Date:	November 2012
Estimated Primary Completion Date:	November 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Celecoxib	Drug: Celecoxib Celecoxib 50 mg or 100 mg PO BID for 6 weeks
Experimental: Naproxen	Drug: Naproxen Naproxen 7.5 mg/kg PO BID [maximum of 500 mg BID] for 6 weeks

Eligibility

Ages Eligible for Study:	2 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Polyarticular (both rheumatoid factor positive and rheumatoid factor negative),oligoarticular and extended oligoarticular JIA for ≥3 months meeting the International League of Associations for Rheumatology (ILAR) criteria for Juvenile Idiopathic Arthritis (JIA)
Subjects with Systemic JIA with active arthritis in at least 1 joint but without active systemic features are eligible
≥2 years of age and <18 years of age prior to the Baseline visit
Body weight ≥10 kg at the Baseline visit
Candidate for chronic NSAID therapy in the Investigator's judgment

Exclusion Criteria:

Psoriatic arthritis, enthesitis-related arthritis, and undifferentiated arthritis types of JIA
Active systemic features over the prior 12 weeks in children with systemic Juvenile Idiopathic Arthritis (JIA)
Subjects with psoriatic arthritis, enthesitis-related arthritis, and undifferentiated arthritis should be excluded
Subjects with active Systemic JIA should not be enrolled

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00807846

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Show 35 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

No publications provided

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT00807846 History of Changes
Other Study ID Numbers:	A3191342
Study First Received:	December 10, 2008
Last Updated:	May 16, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Juvenile Arthritis; Juvenile Rheumatoid Arthritis;Blood Pressure;Juvenile Idiopathic Arthritis

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 May 24, 2012