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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
201
Change From Baseline in Systolic Blood Pressure (SBP) at Week 6/Final Visit
Value at 6 weeks minus value at baseline.
Time frame: 6 Weeks/Final Visit
Change From Baseline to Week 2 in SBP.
Value at 2 weeks minus value at baseline.
Time frame: 2 weeks
Change From Baseline in SBP at Week 4.
Value at 4 weeks minus value at baseline.
Time frame: 4 weeks
Change From Baseline in Diastolic Blood Pressure (DBP) at Week 2.
Value at 2 weeks minus value at baseline.
Time frame: 2 weeks
Change From Baseline in DBP at Week 4.
Value at 4 weeks minus value at baseline.
Time frame: 4 weeks
Change From Baseline in DBP at Week 6/Final Visit
Value at 6 weeks/Final Visit minus value at baseline.
Time frame: 6 weeks
Change From Baseline in Parent's Assessment of Overall Well-being at 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.
Time frame: 6 weeks
Number of Participants With >= 30% Improvement in the Parent's Global Assessment of Overall Well-being at Week 6/Final Visit.
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Catalina Pointe Clinical Research, Inc.
Tucson, Arizona, United States
Arkansas Children's Hospital
Little Rock, Arkansas, United States
Children's Hospital-San Diego
San Diego, California, United States
Connecticut Children's Medical Center
Hartford, Connecticut, United States
Children's National Medical Center / Division of Rheumatology
Washington D.C., District of Columbia, United States
Arthritis Associates of South Florida
Delray Beach, Florida, United States
Delray Research Associates
Delray Beach, Florida, United States
Miami Children's Hospital
Miami, Florida, United States
Administrative Site-Hawaii Pacific Health Research Institute
Honolulu, Hawaii, United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States
...and 29 more locations
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.
Time frame: Week 6/Final Visit
Change From Baseline in Participant's Assessment of Overall Well-being at 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'.
Time frame: 6 weeks
Number of Participants With >= 30% Improvement in the Participant's Global Assessment of Overall Well-being at 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'.
Time frame: Week 6/Final Visit