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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
This study is currently recruiting participants.
Verified by Pfizer, February 2010
First Received: December 10, 2008   Last Updated: February 1, 2010   History of Changes
Sponsor: Pfizer
Information provided by: 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 IV

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


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: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Celecoxib: Experimental Drug: Celecoxib
Celecoxib 50 mg or 100 mg PO BID for 6 weeks
Naproxen: Experimental 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 21 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers: A3191342
Study First Received: December 10, 2008
Last Updated: February 1, 2010
ClinicalTrials.gov Identifier: NCT00807846     History of Changes
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:
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