Clinical trial NCT00652925: A Study to Evaluate the Efficacy and Safety of Celecoxib Suspension Compared to Naproxen Suspension in Patients With JRA
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Arthritis, Juvenile Rheumatoid
Keywords: arthritis
juvenile
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-04-04
Enrollment: 225
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To study Celebrex versus naproxen to see if it decreases symptoms of juvenile arthritis such as pain and swelling.


Eligibility criteria: Inclusion Criteria:

2-18 years old with active JRA

Exclusion Criteria:

other experimental meds, recent changes in arthritis meds

Primary outcomes:
measure: ACR Pediatric 30
timeFrame: 12 weeks
Secondary outcomes:
measure: Peds QOL
timeFrame: 12 weeks
measure: composites of acr 30
timeFrame: 12 weeks
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: Hartford
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Delray Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: St. Petersburg
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Chicago
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Chicago
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Chicago
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Glenview
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Hinsdale
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: Merrillville
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: New Orleans
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Boston
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Worcester
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Omaha
country: United States
facility: Pfizer Investigational Site
state: Nebraska
city: Livingston
country: United States
facility: Pfizer Investigational Site
state: New Jersey
city: New Hyde Park
country: United States
facility: Pfizer Investigational Site
state: New York
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: Tulsa
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Tulsa
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Portland
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Portland
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Portland
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Altoona
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Altoona
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Duncansville
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Hershey
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Johnstown
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Lancaster
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
city: Milwaukee
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
city: Milwaukee
country: United States
facility: Pfizer Investigational Site
state: Wisconsin
city: Leuven
country: Belgium
facility: Pfizer Investigational Site
city: Rio De Janeiro
country: Brazil
facility: Pfizer Investigational Site
state: RJ
city: São Paulo
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: São Paulo
country: Brazil
facility: Pfizer Investigational Site
state: SP
city: Rio de Janeiro
country: Brazil
facility: Pfizer Investigational Site
city: Saskatoon
country: Canada
facility: Pfizer Investigational Site
state: Saskatchewan
city: Århus N
country: Denmark
facility: Pfizer Investigational Site
city: Vandoeuvre-les-nancy
country: France
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Bremen
country: Germany
facility: Pfizer Investigational Site
city: Halle
country: Germany
facility: Pfizer Investigational Site
city: Hamburg
country: Germany
facility: Pfizer Investigational Site
city: Hannover
country: Germany
facility: Pfizer Investigational Site
city: Monterrey
country: Mexico
facility: Pfizer Investigational Site
state: Nuevo Leon
city: Guadalajara
country: Mexico
facility: Pfizer Investigational Site
city: Lima
country: Peru
facility: Pfizer Investigational Site
city: Lima
country: Peru
facility: Pfizer Investigational Site
city: Lima
country: Peru
facility: Pfizer Investigational Site
city: Vila Nova de Famalicao
country: Portugal
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Piestany
country: Slovakia
facility: Pfizer Investigational Site
city: Ljubljana
country: Slovenia
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Valencia
country: Spain
facility: Pfizer Investigational Site
city: Stockholm
country: Sweden
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: