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

Last updated: January 29, 2021
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Overall Status: Completed

Phase

4

Condition

Joint Injuries

Treatment

N/A

Clinical Study ID

NCT00807846
A3191342
  • Ages 2-17
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Polyarticular (both rheumatoid factor positive and rheumatoid factornegative),oligoarticular and extended oligoarticular JIA for ≥3 months meeting theInternational League of Associations for Rheumatology (ILAR) criteria for JuvenileIdiopathic Arthritis (JIA)
  • Subjects with Systemic JIA with active arthritis in at least 1 joint but withoutactive 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

Exclusion Criteria:

  • Psoriatic arthritis, enthesitis-related arthritis, and undifferentiated arthritistypes of JIA
  • Active systemic features over the prior 12 weeks in children with systemic JuvenileIdiopathic Arthritis (JIA)
  • Subjects with psoriatic arthritis, enthesitis-related arthritis, and undifferentiatedarthritis should be excluded
  • Subjects with active Systemic JIA should not be enrolled

Study Design

Total Participants: 201
Study Start date:
September 01, 2009
Estimated Completion Date:
December 31, 2012

Connect with a study center

  • Hospital Roberto del Rio

    Santiago, RM 8380418
    Chile

    Site Not Available

  • Hospital Regional de Concepcion Guillermo Grant Benavente

    Concepcion, VIII Region 4070038
    Chile

    Site Not Available

  • Instituto de Atencion Pediatrica

    San Jose, 00000
    Costa Rica

    Site Not Available

  • Clinica San Borja/Centro de Investigacion de Reumatologia

    San Borja, Lima L41
    Peru

    Site Not Available

  • Clinica Ricardo Palma/Sitio de Investigacion de Reumatologia

    San Isidro, Lima L27
    Peru

    Site Not Available

  • Philippine General Hospital

    Manila, 1000
    Philippines

    Site Not Available

  • University of Santo Tomas Hospital

    Manila, 1008
    Philippines

    Site Not Available

  • First Moscow State Medical University I.M. Sechenov of the Minzdravsocrazvitiya of Russia

    Moscow, 119992
    Russian Federation

    Site Not Available

  • State Healthcare Institution of Moscow "Izmailovskaya City Children's Hospital"

    Moscow, 105077
    Russian Federation

    Site Not Available

  • SEIHPE "Smolensk State Medical Academy"of the Minzdravsocrazvitiya of Russia

    Smolensk, 214019
    Russian Federation

    Site Not Available

  • Smolensk Regional Clinical Hospital

    Smolensk, 214000
    Russian Federation

    Site Not Available

  • Institute of Rheumatology

    Belgrade, 11000
    Serbia

    Site Not Available

  • Children's Clinic of Internal Medicine

    Nis, 18000
    Serbia

    Site Not Available

  • Clinical Research Unit

    Pretoria, Gauteng Province 0001
    South Africa

    Site Not Available

  • CHUV - Unit of Immuno-Allergology and Rhumatology

    Ch-1011 Lausanne,
    Switzerland

    Site Not Available

  • Universitaets-Kinderspital

    Ch-8032 Zuerich,
    Switzerland

    Site Not Available

  • Department of Cardioreumatology

    Kharkiv, 61153
    Ukraine

    Site Not Available

  • Institute of Pediatrics, Obstetrics and Gynecology

    Kiev, 04050
    Ukraine

    Site Not Available

  • Kyiv City Children Clinical Hospital #1

    Kyiv, 04209
    Ukraine

    Site Not Available

  • Crimean State Medical University, Chair of Pediatrics with a course of Children Infectious Diseases

    Simferopol, 95034
    Ukraine

    Site Not Available

  • Zaporizhzhya Regional Clinical Pediatric Hospital

    Zaporizhzhya, 69063
    Ukraine

    Site Not Available

  • Catalina Pointe Clinical Research, Inc.

    Tucson, Arizona 85704
    United States

    Site Not Available

  • Arkansas Children's Hospital

    Little Rock, Arkansas 72202
    United States

    Site Not Available

  • Pfizer Investigational Site

    Los Angeles, California 90027
    United States

    Site Not Available

  • Children's Hospital-San Diego

    San Diego, California 92123
    United States

    Site Not Available

  • Connecticut Children's Medical Center

    Hartford, Connecticut 06106
    United States

    Site Not Available

  • Children's National Medical Center / Division of Rheumatology

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • Arthritis Associates of South Florida

    Delray Beach, Florida 33484
    United States

    Site Not Available

  • Delray Research Associates

    Delray Beach, Florida 33484
    United States

    Site Not Available

  • Miami Children's Hospital

    Miami, Florida 33155-3009
    United States

    Site Not Available

  • Administrative Site-Hawaii Pacific Health Research Institute

    Honolulu, Hawaii 96813
    United States

    Site Not Available

  • Kapiolani Medical Center for Women and Children

    Honolulu, Hawaii 96826
    United States

    Site Not Available

  • Kosair Charities Pediatric Clinical Research Unit - University of Louisville

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Kosair Children's Hospital

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • University Pediatric Rheumatology of Kentucky

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • University of Louisville

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Children's Hospital and Medical Center

    Omaha, Nebraska 68114
    United States

    Site Not Available

  • University of Nebraska Medical Center Pediatric Research Office

    Omaha, Nebraska 68198-5456
    United States

    Site Not Available

  • Akron Children's Hospital

    Akron, Ohio 44308
    United States

    Site Not Available

  • Milton S. Hershey Medical Center

    Hershey, Pennsylvania 17033
    United States

    Site Not Available

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