Arthritis, Juvenile Rheumatoid Clinical Trial
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
| Verified date | April 2008 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
To study Celebrex versus naproxen to see if it decreases symptoms of juvenile arthritis such as pain and swelling.
| Status | Completed |
| Enrollment | 225 |
| Est. completion date | April 2005 |
| Est. primary completion date | April 2004 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 2 Years to 18 Years |
| Eligibility |
Inclusion Criteria: 2-18 years old with active JRA Exclusion Criteria: other experimental meds, recent changes in arthritis meds |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Pfizer Investigational Site | Leuven | |
| Brazil | Pfizer Investigational Site | Rio De Janeiro | RJ |
| Brazil | Pfizer Investigational Site | Rio de Janeiro | |
| Brazil | Pfizer Investigational Site | São Paulo | SP |
| Brazil | Pfizer Investigational Site | São Paulo | SP |
| Canada | Pfizer Investigational Site | Saskatoon | Saskatchewan |
| Denmark | Pfizer Investigational Site | Århus N | |
| France | Pfizer Investigational Site | Vandoeuvre-les-nancy | |
| Germany | Pfizer Investigational Site | Berlin | |
| Germany | Pfizer Investigational Site | Bremen | |
| Germany | Pfizer Investigational Site | Halle | |
| Germany | Pfizer Investigational Site | Hamburg | |
| Germany | Pfizer Investigational Site | Hannover | |
| Mexico | Pfizer Investigational Site | Guadalajara | |
| Mexico | Pfizer Investigational Site | Monterrey | Nuevo Leon |
| Peru | Pfizer Investigational Site | Lima | |
| Peru | Pfizer Investigational Site | Lima | |
| Peru | Pfizer Investigational Site | Lima | |
| Portugal | Pfizer Investigational Site | Vila Nova de Famalicao | |
| Russian Federation | Pfizer Investigational Site | Moscow | |
| Russian Federation | Pfizer Investigational Site | Moscow | |
| Slovakia | Pfizer Investigational Site | Piestany | |
| Slovenia | Pfizer Investigational Site | Ljubljana | |
| Spain | Pfizer Investigational Site | Madrid | |
| Spain | Pfizer Investigational Site | Madrid | |
| Spain | Pfizer Investigational Site | Valencia | |
| Sweden | Pfizer Investigational Site | Stockholm | |
| United States | Pfizer Investigational Site | Altoona | Pennsylvania |
| United States | Pfizer Investigational Site | Altoona | Pennsylvania |
| United States | Pfizer Investigational Site | Boston | Massachusetts |
| United States | Pfizer Investigational Site | Chicago | Illinois |
| United States | Pfizer Investigational Site | Chicago | Illinois |
| United States | Pfizer Investigational Site | Chicago | Illinois |
| United States | Pfizer Investigational Site | Delray Beach | Florida |
| United States | Pfizer Investigational Site | Duncansville | Pennsylvania |
| United States | Pfizer Investigational Site | Glenview | Illinois |
| United States | Pfizer Investigational Site | Hartford | Connecticut |
| United States | Pfizer Investigational Site | Hershey | Pennsylvania |
| United States | Pfizer Investigational Site | Hinsdale | Illinois |
| United States | Pfizer Investigational Site | Johnstown | Pennsylvania |
| United States | Pfizer Investigational Site | Lancaster | Pennsylvania |
| United States | Pfizer Investigational Site | Livingston | New Jersey |
| United States | Pfizer Investigational Site | Merrillville | Indiana |
| United States | Pfizer Investigational Site | Miami | Florida |
| United States | Pfizer Investigational Site | Milwaukee | Wisconsin |
| United States | Pfizer Investigational Site | Milwaukee | Wisconsin |
| United States | Pfizer Investigational Site | New Hyde Park | New York |
| United States | Pfizer Investigational Site | New Orleans | Louisiana |
| United States | Pfizer Investigational Site | New York | New York |
| United States | Pfizer Investigational Site | Omaha | Nebraska |
| United States | Pfizer Investigational Site | Portland | Oregon |
| United States | Pfizer Investigational Site | Portland | Oregon |
| United States | Pfizer Investigational Site | Portland | Oregon |
| United States | Pfizer Investigational Site | San Diego | California |
| United States | Pfizer Investigational Site | St. Petersburg | Florida |
| United States | Pfizer Investigational Site | Tulsa | Oklahoma |
| United States | Pfizer Investigational Site | Tulsa | Oklahoma |
| United States | Pfizer Investigational Site | Worcester | Massachusetts |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
United States, Belgium, Brazil, Canada, Denmark, France, Germany, Mexico, Peru, Portugal, Russian Federation, Slovakia, Slovenia, Spain, Sweden,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | ACR Pediatric 30 | 12 weeks | No | |
| Secondary | Peds QOL | 12 weeks | No | |
| Secondary | composites of acr 30 | 12 weeks | No |
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