More than half of patients with typical gastroesophageal reflux symptoms such as heartburn are considered to have non-erosive reflux disease (NERD), which is characterized by a lack of clinically defined damage to the esophagus. One approach to maintain control of these symptoms is to have medication available on-demand. This is a double-blind, placebo-controlled study of the effectiveness of on-demand rabeprazole in the long-term maintenance of heartburn control in NERD patients, for whom heartburn was resolved with short-term, daily rabeprazole therapy. The study has two phases: an acute phase (4 weeks) during which patients receive rabeprazole medication daily, and an on-demand phase (6 months) during which patients take medication (rabeprazole or placebo) as needed. Only patients who have complete resolution of heartburn at the end of the acute phase are eligible to continue in the on-demand phase. Efficacy assessments include the proportion of patients discontinuing treatment in the on-demand phase because of insufficient heartburn control, and the severity of heartburn and patient satisfaction determined at the beginning and end of on-demand phase. Safety assessments include incidence of adverse events throughout the study, physical examination at study initiation, and vital signs at the beginning and the end of the study. The study hypothesis is that on-demand therapy with rabeprazole is superior to placebo in maintaining heartburn control and is well tolerated by the patients with NERD. Rabeprazole tablet (10 milligrams[mg]) once daily in the morning for 4 weeks. Rabeprazole tablets (10mg) once daily on an on-demand basis for the following 6 months.
The purpose of this study is to assess the efficacy and safety of long-term, on-demand maintenance therapy with rabeprazole in patients with non-erosive reflux disease (NERD).