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

NCT00652925 | Completed Phase 3 DMC

• 2 other identifiers: N49-01-02-195A3191127
• Study Type: interventional
• Target: 225
• Locations: 14 countries
• Sites: 57

Brief Summary

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

Conditions

Arthritis, Juvenile Rheumatoid

Keywords

arthritis; juvenile

Outcome Measures

Primary Outcomes (1)

• ACR Pediatric 30

  12 weeks

Secondary Outcomes (2)

• Peds QOL

  12 weeks

• composites of acr 30

  12 weeks

Study Arms (3)

High Dose

EXPERIMENTAL

Drug: Celecoxib

Low Dose

EXPERIMENTAL

Drug: Celecoxib

Naproxen

ACTIVE COMPARATOR

Control comparator, 15 mg/kg/dy target dose

Drug: Naproxen

Interventions

Celecoxib DRUG

Higher dose, 6 mg/kg/dose BID

High Dose

Naproxen DRUG

Control comparator, 15 mg/kg/dy target dose

Naproxen

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• years old with active JRA

You may not qualify if:

• other experimental meds, recent changes in arthritis meds

Sponsors & Collaborators

• Pfizer: lead

Study Sites (58)

Pfizer Investigational Site

San Diego, California, 92123, United States

Location

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Hartford, Connecticut, 06106, United States

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Delray Beach, Florida, 33484, United States

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Miami, Florida, 33155, United States

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St. Petersburg, Florida, 33701, United States

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Chicago, Illinois, 60614, United States

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Chicago, Illinois, 60637, United States

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Chicago, Illinois, 60649, United States

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Glenview, Illinois, 60025, United States

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Hinsdale, Illinois, 60521, United States

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Merrillville, Indiana, 46410, United States

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New Orleans, Louisiana, 70118, United States

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Boston, Massachusetts, 02115, United States

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Worcester, Massachusetts, 01610, United States

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Omaha, Nebraska, 68178, United States

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Livingston, New Jersey, 07039, United States

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New Hyde Park, New York, 11040, United States

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New York, New York, 10032, United States

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Tulsa, Oklahoma, 74133, United States

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Tulsa, Oklahoma, 74135, United States

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Portland, Oregon, 97210, United States

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Portland, Oregon, 97227-1623, United States

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Portland, Oregon, 97232, United States

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Altoona, Pennsylvania, 16601, United States

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Altoona, Pennsylvania, 16602, United States

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Duncansville, Pennsylvania, 16635, United States

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Hershey, Pennsylvania, 17033, United States

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Johnstown, Pennsylvania, 15904, United States

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Lancaster, Pennsylvania, 17604, United States

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Milwaukee, Wisconsin, 53201, United States

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Milwaukee, Wisconsin, 53226-0509, United States

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Leuven, 3000, Belgium

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Rio de Janeiro, Rio de Janeiro, 20551-030, Brazil

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Rio de Janeiro, Rio de Janeiro, 21944-970, Brazil

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São Paulo, São Paulo, 04025-002, Brazil

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São Paulo, São Paulo, 05403-901, Brazil

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Saskatoon, Saskatchewan, Canada

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Århus N, 8200, Denmark

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Vandœuvre-lès-Nancy, 54511, France

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Berlin, 13125, Germany

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Bremen, 28205, Germany

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Halle, 06120, Germany

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Hamburg, 22081, Germany

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Hanover, 30625, Germany

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Monterrey, Nuevo León, 64460, Mexico

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Guadalajara, 44650, Mexico

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Lima, Lima Province, L05, Peru

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Lima, Lima Province, L13, Peru

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Lima, Lima Province, L31, Peru

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Vila Nova de Famalicão, 4764-901, Portugal

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Moscow, 115522, Russia

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Moscow, 119296, Russia

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Piešťany, 921 01, Slovakia

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Ljubljana, 1525, Slovenia

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Madrid, Madrid, 28009, Spain

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Madrid, Madrid, 28034, Spain

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Valencia, Valencia, 46009, Spain

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Stockholm, SE-17176, Sweden

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Arthritis, Juvenile; Arthritis

Interventions

Celecoxib; Naproxen

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 1, 2008
• First Posted: April 4, 2008
• Study Start: October 1, 2002
• Primary Completion: April 1, 2004
• Study Completion: April 1, 2005
• Last Updated: May 30, 2008

Record last verified: 2008-04

Locations

FR (1); BE (1); DE (5); CA (1); PE (3); RU (2); ES (3); US (31); SE (1); DK (1); PT (1); SL (1); ME (2); BR (4)