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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Value at 6 weeks minus value at baseline.



Original Primary Outcome: 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 ]

Current Secondary Outcome:

  • Change From Baseline to Week 2 in SBP. [ Time Frame: 2 weeks ]
    Value at 2 weeks minus value at baseline.
  • Change From Baseline in SBP at Week 4. [ Time Frame: 4 weeks ]
    Value at 4 weeks minus value at baseline.
  • Change From Baseline in Diastolic Blood Pressure (DBP) at Week 2. [ Time Frame: 2 weeks ]
    Value at 2 weeks minus value at baseline.
  • Change From Baseline in DBP at Week 4. [ Time Frame: 4 weeks ]
    Value at 4 weeks minus value at baseline.
  • Change From Baseline in DBP at Week 6/Final Visit [ Time Frame: 6 weeks ]
    Value at 6 weeks/Final Visit minus value at baseline.
  • Change From Baseline in Parent's Assessment of Overall Well-being at Week 6/Final Visit. [ Time Frame: 6 weeks ]
    The parent/legal guardian evaluated the participant's overall well-being at Baseline and at Week 6 (or Final Visit) by placing one vertical line on the visual analog scale (VAS). The VAS ranged from 0 to 100, with 0 being 'very well' and 100 being 'very poor.
  • Number of Participants With >= 30% Improvement in the Parent's Global Assessment of Overall Well-being at Week 6/Final Visit. [ Time Frame: Week 6/Final Visit ]
    The parent/legal guardian evaluated the participant's overall well-being at Baseline and at Week 6 (or Final Visit) by placing one vertical line on the visual analog scale (VAS). The VAS ranged from 0 to 100, with 0 being 'very well' and 100 being 'very poor.
  • Change From Baseline in Participant's Assessment of Overall Well-being at Week 6/Final Visit. [ Time Frame: 6 weeks ]
    Participants, ≥8 years of age at the baseline, evaluated their own overall well-being at Baseline and at Week 6 (or Final Visit) by placing one vertical line on the VAS. The VAS ranges from 0 to 100, with 0 being 'very well' and 100 being 'very poor'.
  • Number of Participants With >= 30% Improvement in the Participant's Global Assessment of Overall Well-being at Week 6/Final Visit. [ Time Frame: Week 6/Final Visit ]
    Participants, ≥8 years of age at the baseline, evaluated their own overall well-being at Baseline and at Week 6 (or Final Visit) by placing one vertical line on the VAS. The VAS ranges from 0 to 100, with 0 being 'very well' and 100 being 'very poor'.


Original Secondary Outcome:

  • Effect of treatment with celecoxib on diastolic BP (DBP) compared to treatment with naproxen in subjects with JIA [ Time Frame: 6 weeks ]
  • Adverse event profile and GI tolerability of treatment with celecoxib vs. treatment with naproxen in subjects with JIA [ Time Frame: 6 weeks ]
  • 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 ]
  • Effect of celecoxib and naproxen on blood pressure measured by Ambulatory Blood Pressure Monitoring (ABPM) in subjects with JIA [ Time Frame: 6 weeks ]


Information By: Pfizer

Dates:
Date Received: December 10, 2008
Date Started: September 2009
Date Completion:
Last Updated: October 7, 2015
Last Verified: October 2015