A Study To Evaluate The Effects Of Celecoxib (Celebrex®) Or Naproxen On Blood Pressure In Pediatric Subjects
NCT ID: NCT00807846
Last Updated: 2021-02-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
201 participants
INTERVENTIONAL
2009-09-30
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Celecoxib
Celecoxib
Celecoxib 50 mg or 100 mg PO BID for 6 weeks
Naproxen
Naproxen
Naproxen 7.5 mg/kg PO BID \[maximum of 500 mg BID\] for 6 weeks
Interventions
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Celecoxib
Celecoxib 50 mg or 100 mg PO BID for 6 weeks
Naproxen
Naproxen 7.5 mg/kg PO BID \[maximum of 500 mg BID\] for 6 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
2 Years
17 Years
ALL
No
Sponsors
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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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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
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, Región del Biobío, 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
State Healthcare Institution of Moscow "Izmailovskaya City Children's Hospital"
Moscow, , Russia
First Moscow State Medical University I.M. Sechenov of the Minzdravsocrazvitiya of Russia
Moscow, , Russia
Smolensk Regional Clinical Hospital
Smolensk, , Russia
SEIHPE "Smolensk State Medical Academy"of the Minzdravsocrazvitiya of Russia
Smolensk, , Russia
Institute of Rheumatology
Belgrade, , Serbia
Children's Clinic of Internal Medicine
Niš, , Serbia
Clinical Research Unit
Pretoria, Gauteng, South Africa
CHUV - Unit of Immuno-Allergology and Rhumatology
Ch-1011 Lausanne, , Switzerland
Universitaets-Kinderspital
Ch-8032 Zuerich, , Switzerland
Department of Cardioreumatology
Kharkiv, , Ukraine
Institute of Pediatrics, Obstetrics and Gynecology
Kiev, , Ukraine
Kyiv City Children Clinical Hospital #1
Kyiv, , Ukraine
Crimean State Medical University, Chair of Pediatrics with a course of Children Infectious Diseases
Simferopol, , Ukraine
Zaporizhzhya Regional Clinical Pediatric Hospital
Zaporizhzhya, , Ukraine
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A3191342
Identifier Type: -
Identifier Source: org_study_id
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