Gastroesophageal Reflux Clinical Trial
Official title:
A Phase 3b Multicenter, Single-Blind Trial to Evaluate the Efficacy of Dexlansoprazole MR 30 mg in Maintaining Control of Gastroesophageal Reflux Disease Symptoms in Subjects on Prior Twice Daily Proton Pump Inhibitor Therapy
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.
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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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