A Study to Evaluate the Efficacy and Safety of Celecoxib Suspension Compared to Naproxen Suspension in Patients With JRA
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00652925 |
Recruitment Status :
Completed
First Posted : April 4, 2008
Last Update Posted : May 30, 2008
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Arthritis, Juvenile Rheumatoid | Drug: Celecoxib Drug: Naproxen | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 225 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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 Start Date : | October 2002 |
Actual Primary Completion Date : | April 2004 |
Actual Study Completion Date : | April 2005 |

Arm | Intervention/treatment |
---|---|
Experimental: High Dose |
Drug: Celecoxib
Higher dose, 6 mg/kg/dose BID |
Experimental: Low Dose |
Drug: Celecoxib
Active drug at lower dose |
Active Comparator: Naproxen
Control comparator, 15 mg/kg/dy target dose
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Drug: Naproxen
Control comparator, 15 mg/kg/dy target dose |
- ACR Pediatric 30 [ Time Frame: 12 weeks ]
- Peds QOL [ Time Frame: 12 weeks ]
- composites of acr 30 [ Time Frame: 12 weeks ]

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Ages Eligible for Study: | 2 Years to 18 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
2-18 years old with active JRA
Exclusion Criteria:
other experimental meds, recent changes in arthritis meds

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00652925

Study Director: | Pfizer CT.gov Call Center | Pfizer |
Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer |
ClinicalTrials.gov Identifier: | NCT00652925 |
Other Study ID Numbers: |
N49-01-02-195 A3191127 |
First Posted: | April 4, 2008 Key Record Dates |
Last Update Posted: | May 30, 2008 |
Last Verified: | April 2008 |
arthritis juvenile |
Arthritis Arthritis, Juvenile Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Celecoxib Naproxen Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic |
Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase 2 Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Gout Suppressants |