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 (IRB# 31282)
This study will help identify potential effects of both drugs being used during this trial, celecoxib and naproxen. Children with Juvenile Idiopathic Arthritis are commonly prescribed non-steroidal anti-inflammatory drugs to help control the pain caused with this disease. These medications have been found they can cause the blood pressure to rise. This study will closely monitor the blood pressure and hopefully identify the safety and efficacy when being used to treat JIA.
- Males and females with diagnosis of Juvenile idiopathic arthritis for >3 months who weigh >10 Kg (22 lbs)
- Candidate for non-steroidal therapy
- Females of childbearing potential have a negative urine pregnancy test and must agree to use contraception or is abstinence for the duration of the study and 28 days after last dose of study medication.
- Diagnosis of a gastric, esophageal, pyloric channel, duodenal ulceration within 60 days of screening
- Active gastrointestinal disease (Crohn’s disease, inflammatory bowel disease, ulcerative colitis)
- A chronic or acute renal or hepatic disorder
- A significant clotting defect
- Oral or injectable corticosteroids given within 2 weeks of screening/baseline visit.
- Subject’s who are taking any of the following medications: Non-steroidal ant-inflammatory drugs (NSAID) within 48 hours of baseline, anticoagulant, lithium, cyclosporine, tacrolimus and antihypertensives.
Additional Study Details:
What is expected of me and my child?
14 day screening phase, Week 6 and early termination-A medical and medication history, vital signs, height and weight measured, physical exam, blood pressure 3 times, blood tests (approximately 2 tablespoons), if female of childbearing potential a urine pregnancy will be obtained, optional pharmacogenomic sampling. Baseline: Randomization will be completed and study medication will be dispensed along with verbal and written instructions on daily use, global well-being assessment for parent/child, 24 hour blood pressure monitoring. Week 2 and 4-blood pressure 3 times, adverse events and any new medications, dispensing of study medication and review.
- Dr. Scalzi’s clinic at 30 Hope drive.
- Juvenile Arthritis