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: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

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, Tucson, Arizona 85704, United States; Recruiting

Pfizer Investigational Site, Washington, District of Columbia 20010, United States; Not yet recruiting

Pfizer Investigational Site, Akron, Ohio 44308, United States; Not yet recruiting

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

Starting date: September 2009
Ending date: November 2012
Last updated: October 3, 2009