Clinical trial NCT00807846: A Study To Evaluate The Effects Of Celecoxib (Celebrex®) Or Naproxen On Blood Pressure In Pediatric Subjects
Official title: A Phase 4, 6-week, Randomized Double Blind, 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Arthritis, Juvenile Rheumatoid
Keywords: Juvenile Arthritis; Juvenile Rheumatoid Arthritis;Blood Pressure;Juvenile Idiopathic Arthritis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-12-12
Enrollment: 201
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change From Baseline in Systolic Blood Pressure (SBP) at Week 6/Final Visit
timeFrame: 6 Weeks/Final Visit
Secondary outcomes:
measure: Change From Baseline to Week 2 in SBP.
timeFrame: 2 weeks
measure: Change From Baseline in SBP at Week 4.
timeFrame: 4 weeks
measure: Change From Baseline in Diastolic Blood Pressure (DBP) at Week 2.
timeFrame: 2 weeks
measure: Change From Baseline in DBP at Week 4.
timeFrame: 4 weeks
measure: Change From Baseline in DBP at Week 6/Final Visit
timeFrame: 6 weeks
measure: Change From Baseline in Parent's Assessment of Overall Well-being at Week 6/Final Visit.
timeFrame: 6 weeks
measure: Number of Participants With >= 30% Improvement in the Parent's Global Assessment of Overall Well-being at Week 6/Final Visit.
timeFrame: Week 6/Final Visit
measure: Change From Baseline in Participant's Assessment of Overall Well-being at Week 6/Final Visit.
timeFrame: 6 weeks
measure: Number of Participants With >= 30% Improvement in the Participant's Global Assessment of Overall Well-being at Week 6/Final Visit.
timeFrame: Week 6/Final Visit
Other outcomes:
measure: Change From Baseline in Assessment of Ambulatory Blood Pressure Monitoring (ABPM) for SBP and DBP at Week 6/Final Visit
timeFrame: 6 weeks/Final Visit
measure: Change From Baseline in Assessment of ABPM for Heart Rate at Week 6/Final Visit
timeFrame: 6 weeks/Final Visit
measure: Change From Baseline in Assessment of ABPM for SBP and DBP Pressure at Week 6/Final Visit (Sensitivity Analysis Excluding One Participant)
timeFrame: 6 weeks/Final Visit
measure: Change From Baseline in Assessment of ABPM for Heart Rate at Week 6/Final Visit (Sensitivity Analysis Excluding One Participant)
timeFrame: 6 weeks/Final Visit
Locations:
city: Tucson
country: United States
facility: Catalina Pointe Clinical Research, Inc.
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Children's Hospital
state: Arkansas
city: San Diego
country: United States
facility: Children's Hospital-San Diego
state: California
city: Hartford
country: United States
facility: Connecticut Children's Medical Center
state: Connecticut
city: Washington
country: United States
facility: Children's National Medical Center / Division of Rheumatology
state: District of Columbia
city: Delray Beach
country: United States
facility: Arthritis Associates of South Florida
state: Florida
city: Delray Beach
country: United States
facility: Delray Research Associates
state: Florida
city: Miami
country: United States
facility: Miami Children's Hospital
state: Florida
city: Honolulu
country: United States
facility: Administrative Site-Hawaii Pacific Health Research Institute
state: Hawaii
city: Honolulu
country: United States
facility: Kapiolani Medical Center for Women and Children
state: Hawaii
city: Louisville
country: United States
facility: Kosair Charities Pediatric Clinical Research Unit - University of Louisville
state: Kentucky
city: Louisville
country: United States
facility: Kosair Children's Hospital
state: Kentucky
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Louisville
country: United States
facility: University Pediatric Rheumatology of Kentucky
state: Kentucky
city: Omaha
country: United States
facility: Children's Hospital and Medical Center
state: Nebraska
city: Omaha
country: United States
facility: University of Nebraska Medical Center Pediatric Research Office
state: Nebraska
city: Akron
country: United States
facility: Akron Children's Hospital
state: Ohio
city: Hershey
country: United States
facility: Milton S. Hershey Medical Center
state: Pennsylvania
city: Santiago
country: Chile
facility: Hospital Roberto del Rio
state: RM
city: Concepcion
country: Chile
facility: Hospital Regional de Concepcion Guillermo Grant Benavente
state: VIII Region
city: San Jose
country: Costa Rica
facility: Instituto de Atencion Pediatrica
city: San Borja
country: Peru
facility: Clinica San Borja/Centro de Investigacion de Reumatologia
state: Lima
city: San Isidro
country: Peru
facility: Clinica Ricardo Palma/Sitio de Investigacion de Reumatologia
state: Lima
city: Manila
country: Philippines
facility: Philippine General Hospital
city: Manila
country: Philippines
facility: University of Santo Tomas Hospital
city: Moscow
country: Russian Federation
facility: State Healthcare Institution of Moscow "Izmailovskaya City Children's Hospital"
city: Moscow
country: Russian Federation
facility: First Moscow State Medical University I.M. Sechenov of the Minzdravsocrazvitiya of Russia
city: Smolensk
country: Russian Federation
facility: Smolensk Regional Clinical Hospital
city: Smolensk
country: Russian Federation
facility: SEIHPE "Smolensk State Medical Academy"of the Minzdravsocrazvitiya of Russia
city: Belgrade
country: Serbia
facility: Institute of Rheumatology
city: Nis
country: Serbia
facility: Children's Clinic of Internal Medicine
city: Pretoria
country: South Africa
facility: Clinical Research Unit
state: Gauteng Province
city: Ch-1011 Lausanne
country: Switzerland
facility: CHUV - Unit of Immuno-Allergology and Rhumatology
city: Ch-8032 Zuerich
country: Switzerland
facility: Universitaets-Kinderspital
city: Kharkiv
country: Ukraine
facility: Department of Cardioreumatology
city: Kiev
country: Ukraine
facility: Institute of Pediatrics, Obstetrics and Gynecology
city: Kyiv
country: Ukraine
facility: Kyiv City Children Clinical Hospital #1
city: Simferopol
country: Ukraine
facility: Crimean State Medical University, Chair of Pediatrics with a course of Children Infectious Diseases
city: Zaporizhzhya
country: Ukraine
facility: Zaporizhzhya Regional Clinical Pediatric Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: