A Study To Evaluate The Effects Of Celecoxib (Celebrex®) Or Naproxen On Blood Pressure In Pediatric Subjects
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00807846
First received: December 10, 2008
Last updated: January 29, 2013
Last verified: January 2013
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Purpose
This Is A Multicenter, Active-Controlled Trial To Evaluate The Effects Of Celecoxib (Celebrex®) Or Naproxen On Blood Pressure In Pediatric Subjects With Juvenile Idiopathic Arthritis
| Condition | Intervention | Phase |
|---|---|---|
|
Arthritis, Juvenile Rheumatoid |
Drug: Celecoxib Drug: Naproxen |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Phase 4, 6-Week, Randomized Double-Blind, Multicenter, Active-Controlled Trial To Evaluate The Effects Of Celecoxib (Celebrex®) Or Naproxen On Blood Pressure In Pediatric Subjects With Juvenile Idiopathic Arthritis |
Resource links provided by NLM:
Genetics Home Reference related topics:
juvenile idiopathic arthritis
MedlinePlus related topics:
Juvenile Rheumatoid Arthritis
U.S. FDA Resources
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Change from Baseline to Week 6/Final visit in Systolic Blood Pressure [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Change from Baseline to Weeks 2 and 4 in SBP [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
- Change from Baseline to Weeks 2, 4, and 6/Final visit in DBP [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
- Change from Baseline to Week 6/Final visit in the Parent's and Subject's Assessment of Overall Well-Being; [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- Effect of celecoxib and naproxen on blood pressure measured by Ambulatory Blood Pressure Monitoring (ABPM) in subjects with JIA [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
- Adverse event profile and GI tolerability of treatment with celecoxib vs. treatment with naproxen in subjects with JIA [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
| Enrollment: | 201 |
| Study Start Date: | September 2009 |
| Study Completion Date: | December 2012 |
| Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Celecoxib |
Drug: Celecoxib
Celecoxib 50 mg or 100 mg PO BID for 6 weeks
|
| Experimental: Naproxen |
Drug: Naproxen
Naproxen 7.5 mg/kg PO BID [maximum of 500 mg BID] for 6 weeks
|
Eligibility| Ages Eligible for Study: | 2 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Polyarticular (both rheumatoid factor positive and rheumatoid factor negative),oligoarticular and extended oligoarticular JIA for ≥3 months meeting the International League of Associations for Rheumatology (ILAR) criteria for Juvenile Idiopathic Arthritis (JIA)
- Subjects with Systemic JIA with active arthritis in at least 1 joint but without active systemic features are eligible
- ≥2 years of age and <18 years of age prior to the Baseline visit
- Body weight ≥10 kg at the Baseline visit
- Candidate for chronic NSAID therapy in the Investigator's judgment
Exclusion Criteria:
- Psoriatic arthritis, enthesitis-related arthritis, and undifferentiated arthritis types of JIA
- Active systemic features over the prior 12 weeks in children with systemic Juvenile Idiopathic Arthritis (JIA)
- Subjects with psoriatic arthritis, enthesitis-related arthritis, and undifferentiated arthritis should be excluded
- Subjects with active Systemic JIA should not be enrolled
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00807846
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Hide Study LocationsLocations
| United States, Arizona | |
| Pfizer Investigational Site | |
| Tucson, Arizona, United States, 85704 | |
| United States, Arkansas | |
| Pfizer Investigational Site | |
| Little Rock, Arkansas, United States, 72202 | |
| United States, California | |
| Pfizer Investigational Site | |
| San Diego, California, United States, 92123 | |
| United States, Connecticut | |
| Pfizer Investigational Site | |
| Hartford, Connecticut, United States, 06106 | |
| United States, District of Columbia | |
| Pfizer Investigational Site | |
| Washington, District of Columbia, United States, 20010 | |
| United States, Florida | |
| Pfizer Investigational Site | |
| Delray Beach, Florida, United States, 33484 | |
| Pfizer Investigational Site | |
| Miami, Florida, United States, 33155-3009 | |
| United States, Hawaii | |
| Pfizer Investigational Site | |
| Honolulu, Hawaii, United States, 96813 | |
| Pfizer Investigational Site | |
| Honolulu, Hawaii, United States, 96826 | |
| United States, Kentucky | |
| Pfizer Investigational Site | |
| Louisville, Kentucky, United States, 40202 | |
| United States, Nebraska | |
| Pfizer Investigational Site | |
| Omaha, Nebraska, United States, 68114 | |
| Pfizer Investigational Site | |
| Omaha, Nebraska, United States, 68198-5456 | |
| United States, Ohio | |
| Pfizer Investigational Site | |
| Akron, Ohio, United States, 44308 | |
| United States, Pennsylvania | |
| Pfizer Investigational Site | |
| Hershey, Pennsylvania, United States, 17033 | |
| Chile | |
| Pfizer Investigational Site | |
| Santiago, RM, Chile, 8380418 | |
| Pfizer Investigational Site | |
| Concepcion, VIII Region, Chile, 4070038 | |
| Costa Rica | |
| Pfizer Investigational Site | |
| San Jose, Costa Rica, 00000 | |
| Peru | |
| Pfizer Investigational Site | |
| San Borja, Lima, Peru, L41 | |
| Pfizer Investigational Site | |
| San Isidro, Lima, Peru, L27 | |
| Philippines | |
| Pfizer Investigational Site | |
| Manila, Philippines, 1000 | |
| Pfizer Investigational Site | |
| Manila, Philippines, 1008 | |
| Russian Federation | |
| Pfizer Investigational Site | |
| Moscow, Russian Federation, 119992 | |
| Pfizer Investigational Site | |
| Moscow, Russian Federation, 105077 | |
| Pfizer Investigational Site | |
| Smolensk, Russian Federation, 214000 | |
| Pfizer Investigational Site | |
| Smolensk, Russian Federation, 214019 | |
| Serbia | |
| Pfizer Investigational Site | |
| Belgrade, Serbia, 11000 | |
| Pfizer Investigational Site | |
| Nis, Serbia, 18000 | |
| South Africa | |
| Pfizer Investigational Site | |
| Pretoria, Gauteng Province, South Africa, 0001 | |
| Switzerland | |
| Pfizer Investigational Site | |
| CH-1011 Lausanne, Switzerland | |
| Pfizer Investigational Site | |
| CH-8032 Zuerich, Switzerland | |
| Ukraine | |
| Pfizer Investigational Site | |
| Kharkiv, Ukraine, 61153 | |
| Pfizer Investigational Site | |
| Kiev, Ukraine, 04050 | |
| Pfizer Investigational Site | |
| Kyiv, Ukraine, 04209 | |
| Pfizer Investigational Site | |
| Simferopol, Ukraine, 95034 | |
| Pfizer Investigational Site | |
| Zaporizhzhya, Ukraine, 69063 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00807846 History of Changes |
| Other Study ID Numbers: | A3191342 |
| Study First Received: | December 10, 2008 |
| Last Updated: | January 29, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
Juvenile Arthritis; Juvenile Rheumatoid Arthritis;Blood Pressure;Juvenile Idiopathic Arthritis |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Juvenile Rheumatoid Joint Diseases Musculoskeletal Diseases Arthritis, Rheumatoid Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Naproxen Celecoxib Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics |
Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Gout Suppressants Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Central Nervous System Agents Cyclooxygenase 2 Inhibitors |
ClinicalTrials.gov processed this record on June 17, 2013