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A Study to Evaluate the Efficacy and Safety of Celecoxib Suspension Compared to Naproxen Suspension in Patients With JRA

Last updated on November 9, 2019

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Study Location
Pfizer Investigational Site
San Diego, California, 92123 United States
Contact
1-800-718-1021
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
2-18 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

2-18 years old with active JRA

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

other experimental meds, recent changes in arthritis meds

NCT00652925
Pfizer
Completed
A Study to Evaluate the Efficacy and Safety of Celecoxib Suspension Compared to Naproxen Suspension in Patients With JRA

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Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Efficacy and Safety of Celecoxib Suspension Compared to Naproxen Suspension in Patients With JRA
Official Title  ICMJE Randomized, Double-Blind, Multicenter, Active Controlled Parallel Group Study to Evaluate the Efficacy and Safety of Celecoxib Suspension Compared to Naproxen Suspension in Patients With JRA
Brief SummaryTo study Celebrex versus naproxen to see if it decreases symptoms of juvenile arthritis such as pain and swelling.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Arthritis, Juvenile Rheumatoid
Intervention  ICMJE
  • Drug: Celecoxib
    Higher dose, 6 mg/kg/dose BID
  • Drug: Celecoxib
    Active drug at lower dose
  • Drug: Naproxen
    Control comparator, 15 mg/kg/dy target dose
Study Arms  ICMJE
  • Experimental: High Dose
    Intervention: Drug: Celecoxib
  • Experimental: Low Dose
    Intervention: Drug: Celecoxib
  • Active Comparator: Naproxen
    Control comparator, 15 mg/kg/dy target dose
    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: April 3, 2008)
225
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2005
Actual Primary Completion DateApril 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

2-18 years old with active JRA

Exclusion Criteria:

other experimental meds, recent changes in arthritis meds

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 2 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Brazil,   Canada,   Denmark,   France,   Germany,   Mexico,   Peru,   Portugal,   Russian Federation,   Slovakia,   Slovenia,   Spain,   Sweden,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00652925
Other Study ID Numbers  ICMJE N49-01-02-195
A3191127
Has Data Monitoring CommitteeYes
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateApril 2008

ICMJE     Data element required by the

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

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1-800-718-1021

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