Can ACIPHEX be used to treat symptomatic GERD in adolescent patients?
One ACIPHEX 20-mg tablet daily is indicated for the treatment of daytime and nighttime heartburn and other symptoms associated with GERD in adults and adolescents 12 years of age and above. Use of ACIPHEX in adolescent patients 12 years of age and above for short-term treatment of GERD is supported by extrapolation of results from adequate and well-controlled studies that supported the approval of ACIPHEX for adults and safety and pharmacokinetic studies performed in adolescent patients. The safety and effectiveness of ACIPHEX for the treatment of GERD patients <12 years of age have not been established. The safety and effectiveness of ACIPHEX for other uses in patients <18 years of age have not been established. In a multicenter, randomized, open-label, parallel-group study, 111 adolescent patients 12 to 16 years of age with a clinical diagnosis of symptomatic GERD or suspected or endoscopically proven GERD were randomized and treated with either ACIPHEX 10 mg* or ACIPHEX 20 mg once d
