A Study To Evaluate The Effects Of Celecoxib (Celebrex®) Or Naproxen On Blood Pressure In Pediatric Subjects
- Registration Number
- NCT00807846
- Lead Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 201
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Celecoxib Celecoxib - Naproxen Naproxen -
- Primary Outcome Measures
Name Time Method Change From Baseline in Systolic Blood Pressure (SBP) at Week 6/Final Visit 6 Weeks/Final Visit Value at 6 weeks minus value at baseline.
- Secondary Outcome Measures
Name Time Method Number of Participants With >= 30% Improvement in the Participant's Global Assessment of Overall Well-being at Week 6/Final Visit. 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'.
Change From Baseline to Week 2 in SBP. 2 weeks Value at 2 weeks minus value at baseline.
Change From Baseline in SBP at Week 4. 4 weeks Value at 4 weeks minus value at baseline.
Change From Baseline in Diastolic Blood Pressure (DBP) at Week 2. 2 weeks Value at 2 weeks minus value at baseline.
Change From Baseline in DBP at Week 4. 4 weeks Value at 4 weeks minus value at baseline.
Change From Baseline in DBP at Week 6/Final Visit 6 weeks Value at 6 weeks/Final Visit minus value at baseline.
Number of Participants With >= 30% Improvement in the Parent's Global Assessment of Overall Well-being at Week 6/Final Visit. 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 Parent's Assessment of Overall Well-being at Week 6/Final Visit. 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.
Change From Baseline in Participant's Assessment of Overall Well-being at Week 6/Final Visit. 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'.
Trial Locations
- Locations (39)
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, 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
Scroll for more (29 remaining)Catalina Pointe Clinical Research, Inc.🇺🇸Tucson, Arizona, United States