A Study To Evaluate The Effects Of Celecoxib (Celebrex®) Or Naproxen On Blood Pressure In Pediatric Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00807846
First received: December 10, 2008
Last updated: January 29, 2013
Last verified: January 2013
  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:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change from Baseline to Week 6/Final visit in Systolic Blood Pressure [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change from Baseline to Weeks 2 and 4 in SBP [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
  • Change from Baseline to Weeks 2, 4, and 6/Final visit in DBP [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
  • Change from Baseline to Week 6/Final visit in the Parent's and Subject's Assessment of Overall Well-Being; [ 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 ]
  • 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 ]

Enrollment: 201
Study Start Date: September 2009
Study Completion Date: December 2012
Primary Completion Date: December 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

  Show 35 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
ClinicalTrials.gov Identifier: NCT00807846     History of Changes
Other Study ID Numbers: A3191342
Study First Received: December 10, 2008
Last Updated: January 29, 2013
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, Juvenile Rheumatoid
Arthritis
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 April 17, 2014