Multicenter, Double-Blind, Placebo-Controlled Crossover Study to Assess the Acute Prokinetic Efficacy of Nizatidine-Controlled Release (150 and 300 mg) in Patients With Gastroesophageal Reflux Disease

Abstract

IntroductionThe aim of the study is to test whether nizatidine delivered via a unique bimodal pulsatile-controlled release system, nizatidine controlled release (CR), accelerates gastric emptying in patients with gastroesophageal reflux disease (GERD). MethodsCombined data were analyzed on 39 patients with delayed gastric emptying (DGE) from 2 studies (n=84) assessing the prokinetic effect of nizatidine CR. A single-blind placebo baseline was followed by double-blind nizatidine CR (150 and 300mg) in randomized sequence, 2 to 5days apart. Each dose was followed 1hour later by an egg-beater meal, labeled with Tc99m. Gamma camera images were obtained at meal completion, 1-, 2-, 3- and 4-hour postmeal. All the 84 patients were classified at baseline with DGE (gastric retention >6.3% at 4hours) or normal gastric emptying. ResultsIn the 39 patients identified with DGE, change from placebo baseline (CFB) for percent gastric retention at 4-hour postmeal with nizatidine CR (150 and 300mg) was each improved and statistically significant (P < 0.05). In a subgroup of diabetic patients with DGE (n=10), the CFB with nizatidine CR (300mg) was significant (P < 0.05) at 3- and 4-hour postmeal. ConclusionsNizatidine CR (150 and 300mg) significantly enhanced gastric emptying of a standard meal in patients with GERD with DGE.