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

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NCT00807846

Last updated on May 10, 2018
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FOR MORE INFORMATION
Study Location
Catalina Pointe Clinical Research, Inc.
Tucson, Arizona, 85704 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Juvenile Rheumatoid Arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
2-17 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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

- Body weight ≥10 kg at the Baseline visit

- Candidate for chronic NSAID therapy in the Investigator's judgment

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT00807846
Pfizer
Completed
A Study To Evaluate The Effects Of Celecoxib (Celebrex®) Or Naproxen On Blood Pressure In Pediatric Subjects

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A Study To Evaluate The Effects Of Celecoxib (Celebrex®) Or Naproxen On Blood Pressure In Pediatric Subjects
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.
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
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Arthritis, Juvenile Rheumatoid
  • Drug: Celecoxib
    Celecoxib 50 mg or 100 mg PO BID for 6 weeks
  • Drug: Naproxen
    Naproxen 7.5 mg/kg PO BID [maximum of 500 mg BID] for 6 weeks
  • Experimental: Celecoxib
    Intervention: Drug: Celecoxib
  • Experimental: Naproxen
    Intervention: Drug: Naproxen
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
201
December 2012
December 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
2 Years to 17 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Chile,   Costa Rica,   Peru,   Philippines,   Russian Federation,   Serbia,   South Africa,   Switzerland,   Ukraine,   United States
 
 
NCT00807846
A3191342
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2015

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

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1-800-718-1021

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