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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 May 11, 2018

FOR MORE INFORMATION
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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A Study to Evaluate the Efficacy and Safety of Celecoxib Suspension Compared to Naproxen Suspension in Patients With JRA
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
To study Celebrex versus naproxen to see if it decreases symptoms of juvenile arthritis such as pain and swelling.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Arthritis, Juvenile Rheumatoid
  • 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
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
225
April 2005
April 2004   (Final data collection date for primary outcome measure)

Inclusion Criteria:

2-18 years old with active JRA

Exclusion Criteria:

other experimental meds, recent changes in arthritis meds

Sexes Eligible for Study: All
2 Years to 18 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Brazil,   Canada,   Denmark,   France,   Germany,   Mexico,   Peru,   Portugal,   Russian Federation,   Slovakia,   Slovenia,   Spain,   Sweden,   United States
 
 
NCT00652925
N49-01-02-195
A3191127
Yes
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2008

ICMJE     Data element required by the

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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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