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

NCT00652925

Last updated date
Study Location
Pfizer Investigational Site
San Diego, California, 92123, United States
Contact
1-800-718-1021

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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
2-18 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

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Juvenile Rheumatoid ArthritisA Study to Evaluate the Efficacy and Safety of Celecoxib Suspension Compared to Naproxen Suspension in Patients With JRA
NCT00652925
  1. San Diego, California
  2. Hartford, Connecticut
  3. Delray Beach, Florida
  4. Miami, Florida
  5. St. Petersburg, Florida
  6. Chicago, Illinois
  7. Chicago, Illinois
  8. Chicago, Illinois
  9. Glenview, Illinois
  10. Hinsdale, Illinois
  11. Merrillville, Indiana
  12. New Orleans, Louisiana
  13. Boston, Massachusetts
  14. Worcester, Massachusetts
  15. Omaha, Nebraska
  16. Livingston, New Jersey
  17. New Hyde Park, New York
  18. New York, New York
  19. Tulsa, Oklahoma
  20. Tulsa, Oklahoma
  21. Portland, Oregon
  22. Portland, Oregon
  23. Portland, Oregon
  24. Altoona, Pennsylvania
  25. Altoona, Pennsylvania
  26. Duncansville, Pennsylvania
  27. Hershey, Pennsylvania
  28. Johnstown, Pennsylvania
  29. Lancaster, Pennsylvania
  30. Milwaukee, Wisconsin
  31. Milwaukee, Wisconsin
  32. Leuven,
  33. Rio De Janeiro, RJ
  34. São Paulo, SP
  35. São Paulo, SP
  36. Rio de Janeiro,
  37. Saskatoon, Saskatchewan
  38. Århus N,
  39. Vandoeuvre-les-nancy,
  40. Berlin,
  41. Bremen,
  42. Halle,
  43. Hamburg,
  44. Hannover,
  45. Monterrey, Nuevo Leon
  46. Guadalajara,
  47. Lima,
  48. Lima,
  49. Lima,
  50. Vila Nova de Famalicao,
  51. Moscow,
  52. Moscow,
  53. Piestany,
  54. Ljubljana,
  55. Madrid,
  56. Madrid,
  57. Valencia,
  58. Stockholm,
ALL GENDERS
2 Years+
years
MULTIPLE SITES
Advanced Information
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 Summary To study Celebrex versus naproxen to see if it decreases symptoms of juvenile arthritis such as pain and swelling.
Detailed Description Not 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 Date April 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 Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date April 2008

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