Pfizer Celecoxib has met its primary endpoint in a Phase IV trial evaluating its effects on blood pressure in paediatric patients with juvenile idiopathic arthritis (JIA).
No virtual difference in the primary and secondary endpoints, systolic blood pressure and diastolic blood pressure, between the celecoxib and naproxen treatment groups were noted.
A similar safety profile was observed in both the groups. Headache, nausea and joint aches were the most common adverse events reported in both treatment groups.
The double-blind, multicentre study was conducted for six weeks to evaluate 50mg or 100mg Celecoxib twice a day or 7.5mg/kg naproxen twice a day.
A total of 201 patients from 10 different countries diagnosed with JIA, including patients with oligoarticular JIA (where few joints are affected) and polyarticular JIA (where many joints are affected), participated in the study.
The company carried out the study as part of a post-marketing commitment to the US Food and Drug Administration for Celebrex.
Image: Pfizer celebrex has been approved by the FDA for the relief of the signs and symptoms of JRA in pediatric patients two years of age and older. Photo: Courtesy of Jim Henderson.