Safety Profile of Rabeprazole in Patients Aged 12–16 Years with Gastroesophageal Reflux Disease (GERD)

Abstract

Purpose: To establish the safety profile of single and repeat doses of rabeprazole sodium (RAB) 10 mg or 20 mg tablets in children with GERD. Methods: This multicenter, open-label trial stratified 24 patients with GERD symptoms into 2 groups (aged 12– < 14 and 14–16 yr) then randomized them to a single morning dose of RAB 10 mg or 20 mg for 5 or 7 days. Following enrollment and safety evaluation of 10-mg group patients, patients were enrolled in the 20-mg group. All patients underwent complete physical examinations at screening and discharge. Blood pressure, pulse, and temperature were recorded at baseline and throughout the study. ECGs and lab tests were performed predose and 12 h postdose on day 1 and at discharge. Safety variables assessed included adverse events (AEs), serious AEs (SAEs), and treatment-emergent signs and symptoms (TESS). Treatment-emergent abnormal (lab) values (TEAVs) were summarized. Clinical evaluations and safety and AE monitoring were reviewed throughout the study. Results: 24 patients (male, n = 11; mean weight, 65.66 kg) were enrolled (12– < 14 yr, n = 8; 14–16 yr, n = 16); 12 patients were randomized in each RAB group. Preliminary results showed no statistically significant differences between treatments in N patients with AEs. Almost all AEs were mild: 10 patients (41.7%) reported mild AEs; 1 patient (4.2%) reported a moderate AE (dysmenorrhea). 5 patients (20.8%) had AEs considered possibly study-drug related (0 probably related). No deaths or SAEs were reported. No patient discontinued due to AEs. Incidence of TESS was 45.8%, with headache most frequently reported (4 patients, 16.7%), followed by nausea (2 patients, 8.3%). 6 patients (25.0%) had TEAVs (RAB 10 mg: elevated potassium [2] and low calcium [1]; RAB 20 mg: elevated potassium [1] and eosinophils [1] and low neutrophils [1]). No TEAV was considered clinically significant by the investigator. There were no clinically significant changes from baseline to discharge in ECGs, hematology, chemistry, or urinalysis. Conclusions: RAB 10 and 20 mg was well tolerated in patients with GERD aged 12–16 yr with no notable differences in overall safety between treatment groups. On behalf of the Study 119 Pediatric Trial Investigators. Research supported by Eisai Medical Research Inc., Ridgefield Park, New Jersey, USA.