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

NCT ID: NCT00652925

Last Updated: 2008-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

225 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-10-31

Study Completion Date

2005-04-30

Brief Summary

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

Detailed Description

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Conditions

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Arthritis, Juvenile Rheumatoid

Keywords

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arthritis juvenile

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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High Dose

Group Type EXPERIMENTAL

Celecoxib

Intervention Type DRUG

Higher dose, 6 mg/kg/dose BID

Low Dose

Group Type EXPERIMENTAL

Celecoxib

Intervention Type DRUG

Active drug at lower dose

Naproxen

Control comparator, 15 mg/kg/dy target dose

Group Type ACTIVE_COMPARATOR

Naproxen

Intervention Type DRUG

Control comparator, 15 mg/kg/dy target dose

Interventions

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Celecoxib

Higher dose, 6 mg/kg/dose BID

Intervention Type DRUG

Celecoxib

Active drug at lower dose

Intervention Type DRUG

Naproxen

Control comparator, 15 mg/kg/dy target dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

2-18 years old with active JRA

Exclusion Criteria

other experimental meds, recent changes in arthritis meds
Minimum Eligible Age

2 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

San Diego, California, United States

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Hartford, Connecticut, United States

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Delray Beach, Florida, United States

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Miami, Florida, United States

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St. Petersburg, Florida, United States

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Chicago, Illinois, United States

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Chicago, Illinois, United States

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Chicago, Illinois, United States

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Glenview, Illinois, United States

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Hinsdale, Illinois, United States

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Merrillville, Indiana, United States

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New Orleans, Louisiana, United States

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Boston, Massachusetts, United States

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Worcester, Massachusetts, United States

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Omaha, Nebraska, United States

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Livingston, New Jersey, United States

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New Hyde Park, New York, United States

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New York, New York, United States

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Tulsa, Oklahoma, United States

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Tulsa, Oklahoma, United States

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Portland, Oregon, United States

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Portland, Oregon, United States

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Portland, Oregon, United States

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Altoona, Pennsylvania, United States

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Altoona, Pennsylvania, United States

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Duncansville, Pennsylvania, United States

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Hershey, Pennsylvania, United States

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Johnstown, Pennsylvania, United States

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Lancaster, Pennsylvania, United States

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Milwaukee, Wisconsin, United States

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Milwaukee, Wisconsin, United States

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Leuven, , Belgium

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Rio de Janeiro, Rio de Janeiro, Brazil

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Rio de Janeiro, Rio de Janeiro, Brazil

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São Paulo, São Paulo, Brazil

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São Paulo, São Paulo, Brazil

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Saskatoon, Saskatchewan, Canada

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Århus N, , Denmark

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Vandœuvre-lès-Nancy, , France

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Berlin, , Germany

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Bremen, , Germany

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Halle, , Germany

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Hamburg, , Germany

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Hanover, , Germany

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Monterrey, Nuevo León, Mexico

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Guadalajara, , Mexico

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Lima, Lima Province, Peru

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Lima, Lima Province, Peru

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Lima, Lima Province, Peru

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Vila Nova de Famalicão, , Portugal

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Moscow, , Russia

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Moscow, , Russia

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Piešťany, , Slovakia

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Ljubljana, , Slovenia

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Madrid, Madrid, Spain

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Madrid, Madrid, Spain

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Valencia, Valencia, Spain

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Stockholm, , Sweden

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Countries

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United States Belgium Brazil Canada Denmark France Germany Mexico Peru Portugal Russia Slovakia Slovenia Spain Sweden

Related Links

Other Identifiers

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A3191127

Identifier Type: -

Identifier Source: secondary_id

N49-01-02-195

Identifier Type: -

Identifier Source: org_study_id