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

Condition(s) targeted: Arthritis, Juvenile Rheumatoid

Intervention: Celecoxib (Drug); Naproxen (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021

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

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: The primary objective of the study is to evaluate the effect of treatment with celecoxib on systolic BP (SBP) compared to treatment with naproxen in subjects with Juvenile Idiopathic Arthritis

Secondary outcome:

Effect of treatment with celecoxib on diastolic BP (DBP) compared to treatment with naproxen in subjects with JIA

Adverse event profile and GI tolerability of treatment with celecoxib vs. treatment with naproxen in subjects with JIA

Effect of treatment with celecoxib on Parent's and Subject's Global Assessment of Overall Well-Being compared to treatment with naproxen in subjects with JIA

Effect of celecoxib and naproxen on blood pressure measured by Ambulatory Blood Pressure Monitoring (ABPM) in subjects with JIA

Minimum age: 2 Years. Maximum age: 18 Years. Gender(s): Both.

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

Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Pfizer Investigational Site, San Jose 00000, Costa Rica; Recruiting

Pfizer Investigational Site, Manila 1008, Philippines; Recruiting

Pfizer Investigational Site, Manila, Philippines; Recruiting

Pfizer Investigational Site, Moscow 105077, Russian Federation; Terminated

Pfizer Investigational Site, Moscow 119992, Russian Federation; Completed

Pfizer Investigational Site, Smolensk 214000, Russian Federation; Completed

Pfizer Investigational Site, Smolensk 214019, Russian Federation; Completed

Pfizer Investigational Site, Belgrade 11000, Serbia; Recruiting

Pfizer Investigational Site, Nis 18000, Serbia; Recruiting

Pfizer Investigational Site, CH-1011 Lausanne, Switzerland; Recruiting

Pfizer Investigational Site, CH-8032 Zuerich, Switzerland; Recruiting

Pfizer Investigational Site, Kharkiv 61153, Ukraine; Recruiting

Pfizer Investigational Site, Kiev 04050, Ukraine; Recruiting

Pfizer Investigational Site, Kyiv 04209, Ukraine; Recruiting

Pfizer Investigational Site, Simferopol 95034, Ukraine; Recruiting

Pfizer Investigational Site, Zaporizhzhya 69063, Ukraine; Recruiting

Pfizer Investigational Site, Tucson, Arizona 85704, United States; Recruiting

Pfizer Investigational Site, Little Rock, Arkansas 72202, United States; Recruiting

Pfizer Investigational Site, Los Angeles, California 90027, United States; Not yet recruiting

Pfizer Investigational Site, San Diego, California 92123, United States; Terminated

Pfizer Investigational Site, Hartford, Connecticut 06106, United States; Recruiting

Pfizer Investigational Site, Washington, District of Columbia 20010, United States; Completed

Pfizer Investigational Site, Delray Beach, Florida 33484, United States; Completed

Pfizer Investigational Site, Miami, Florida 33155-3009, United States; Completed

Pfizer Investigational Site, Pretoria, Gauteng Province 0001, South Africa; Recruiting

Pfizer Investigational Site, Honolulu, Hawaii 96826, United States; Recruiting

Pfizer Investigational Site, Honolulu, Hawaii 96813, United States; Recruiting

Pfizer Investigational Site, Louisville, Kentucky 40202, United States; Recruiting

Pfizer Investigational Site, San Borja, Lima L41, Peru; Recruiting

Pfizer Investigational Site, San Isidro, Lima L27, Peru; Recruiting

Pfizer Investigational Site, Omaha, Nebraska 68198-5456, United States; Recruiting

Pfizer Investigational Site, Akron, Ohio 44308, United States; Recruiting

Pfizer Investigational Site, Hershey, Pennsylvania 17033, United States; Recruiting

Pfizer Investigational Site, Santiago, RM 8380418, Chile; Recruiting

Pfizer Investigational Site, Concepcion, VIII Region 4070038, Chile; Recruiting

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

Starting date: September 2009
Last updated: November 7, 2011