J Pediatr Gastroenterol Nutr 2002; 35 Suppl 4

In a phase I/II, open-label, multicenteric (11 sites) study, 66 children with GERD and erosive esophagitis were treated with lansoprazole -15 mg for children < 30 kg (0.6-1.2mg/kg/day) and 30 mg for children > 30 kg (0.7-0.9mg/kg/day) once daily for 8 to 12 weeks. In patients who were symptomatic even 2 weeks after treatment, the dose of lansoprasole was increased to 60mg daily. All the children responded symptomatically to the above therapy. Commonest side effects seen were constipation in 3 children and headache in 2 children. Mean fasting serum gastrin levels were significantly increased from 58.0 pg/mL at baseline to 112.4 pg/mL at week 2 and 121.9 pg/mL at the final visit. Thus, though this study concluded that lansoprazole is safe in children, its effect on gastrin level seems to be investigated further. Also this study group seems to be too small, and to determine its efficacy in children, a longer study with more number of patients should be evaluated.


Last updated on 25-03-2003