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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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 July 29, 2014