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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
History of Changes

December 10, 2008
January 29, 2013
September 2009
December 2012   (final data collection date for primary outcome measure)
Change from Baseline to Week 6/Final visit in Systolic Blood Pressure [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
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 ]
Complete list of historical versions of study NCT00807846 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
A Study To Evaluate The Effects Of Celecoxib (Celebrex®) Or Naproxen On Blood Pressure In Pediatric Subjects
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

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
Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Arthritis, Juvenile Rheumatoid
  • Drug: Celecoxib
    Celecoxib 50 mg or 100 mg PO BID for 6 weeks
  • Drug: Naproxen
    Naproxen 7.5 mg/kg PO BID [maximum of 500 mg BID] for 6 weeks
  • Experimental: Celecoxib
    Intervention: Drug: Celecoxib
  • Experimental: Naproxen
    Intervention: Drug: Naproxen
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
201
December 2012
December 2012   (final data collection date for primary outcome measure)

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
Both
2 Years to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Chile,   Costa Rica,   Peru,   Philippines,   Russian Federation,   Serbia,   South Africa,   Switzerland,   Ukraine
 
NCT00807846
A3191342
Yes
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP