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

Completed · Phase 4

Conditions studied: Arthritis, Juvenile Rheumatoid

In brief

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

Key facts

Study ID

NCT00807846

Run by

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

People needed

201

Starts

2009-09-01

Expected to finish

2012-12-01

Last updated by the study team

2021-02-02

Who can join

Age: 2 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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
• Kosair Charities Pediatric Clinical Research Unit - University of Louisville — Louisville, Kentucky, United States
• Kosair Children's Hospital — Louisville, Kentucky, United States
• University of Louisville — Louisville, Kentucky, United States
• University Pediatric Rheumatology of Kentucky — Louisville, Kentucky, United States
• Children's Hospital and Medical Center — Omaha, Nebraska, United States
• University of Nebraska Medical Center Pediatric Research Office — Omaha, Nebraska, United States
• Akron Children's Hospital — Akron, Ohio, United States
• Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States
• Hospital Regional de Concepcion Guillermo Grant Benavente — Concepción, Biobio, Chile
• Hospital Roberto del Rio — Santiago, RM, Chile
• Instituto de Atencion Pediatrica — San José, Costa Rica
• Clinica San Borja/Centro de Investigacion de Reumatologia — San Borja, Lima region, Peru
• Clinica Ricardo Palma/Sitio de Investigacion de Reumatologia — San Isidro, Lima region, Peru
• Philippine General Hospital — Manila, Philippines
• University of Santo Tomas Hospital — Manila, Philippines

Full record on ClinicalTrials.gov

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