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

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NCT00807846

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Study Location
Catalina Pointe Clinical Research, Inc.
Tucson, Arizona, 85704, United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

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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 <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
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

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Study To Evaluate The Effects Of Celecoxib (Celebrex®) Or Naproxen On Blood Pressure In Pediatric Subjects
Official Title  ICMJE 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.
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Arthritis, Juvenile Rheumatoid
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Celecoxib
    Intervention: Drug: Celecoxib
  • Experimental: Naproxen
    Intervention: Drug: Naproxen
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 29, 2013)		201
Original Estimated Enrollment  ICMJE
 (submitted: December 10, 2008)		200
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 2 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Chile,   Costa Rica,   Peru,   Philippines,   Russian Federation,   Serbia,   South Africa,   Switzerland,   Ukraine,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00807846
Other Study ID Numbers  ICMJE A3191342
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date October 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP