Conditions: Gastroesophageal Reflux
Keywords: Esophageal Reflux Gastro-Esophageal Reflux Gastroesophageal Reflux Disease GERD Regurgitation, Gastric Heartburn Drug Therapy
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 178
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine if patients with well-controlled heartburn symptoms on twice-daily proton pump inhibitor therapy remain well-controlled after stepping down to once-daily (QD) dexlansoprazole modified release (MR) 30 mg.

Detailed description:
Gastroesophageal reflux disease is recognized as a common and persistent medical problem in the US adult population. Gastroesophageal reflux disease comprises a spectrum of acid-related disorders including symptomatic nonerosive gastroesophageal reflux disease and erosive esophagitis. It affects men and women in nearly equal proportions, and the severity and intensity of heartburn symptoms may be similar in both types of patients.

Dexlansoprazole modified release is a dual delayed release formulation that consists of two types of granules contained in a single capsule. This dual delayed release formulation is designed to extend the duration of drug exposure and maintain pharmacologically active levels over a longer time period.

The purpose of this study is to demonstrate that participants with gastroesophageal reflux disease whose symptoms are well-controlled on twice daily proton pump inhibitors, remain well-controlled when switched to dexlansoprazole MR.

Arms:
arm 1: None

Interventions: intervention 1: Dexlansoprazole MR QD
Intervention descriptions: intervention 1: Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.

Protocol document: