Efficacy and Safety of Dexlansoprazole Modified Release Formulation to Treat Heartburn
Gastroesophageal Reflux Disease
About this trial
This is an interventional treatment trial for Gastroesophageal Reflux Disease focused on measuring Non-Erosive Gastroesophageal Reflux Disease (GERD), Heartburn
Eligibility Criteria
Inclusion Criteria: Subjects with Non-Erosive Gastroesophageal Reflux Disease identifying their main symptom as heartburn. History of episodes of heartburn for 6 months or longer prior to screening. History of episodes of heartburn for 4 or more days during the 7 days prior to Day -1 as recorded in the electronic diary. Exclusion Criteria: Use of prescription or non-prescription proton pump inhibitors (PPIs), histamine (H2) receptor antagonists, sucralfate, misoprostol or prokinetics throughout the study· Use of antacids (except for study supplied Gelusil®). Use of drugs with significant anticholinergic effects. Need for continuous anticoagulant (blood thinner) therapy. Endoscopic Barrett's esophagus and/or definite dysplastic changes in the esophagus. History of dilatation of esophageal strictures, other than a Schatzki's ring (a ring of mucosal tissue near the lower esophageal sphincter). Current or historical evidence of Zollinger-Ellison syndrome or other hypersecretory condition. History of gastric, duodenal or esophageal surgery except simple oversew of an ulcer. Acute upper gastrointestinal (UGI) hemorrhage within 4 weeks of the screening endoscopy. Erosive Esophagitis seen on endoscopy during study screening. Co-existing diseases affecting the esophagus. Abnormal laboratory values that suggest significant clinical disease. Known acquired immunodeficiency syndrome (AIDS) Females pregnant or lactating. History of Alcohol abuse. History of Cancer within 3 years prior to screening. Chronic (>12 doses per month) use of nonsteroidal anti-inflammatory drugs (NSAIDs) or cyclo-oxygenase-2 (COX-2) inhibitors Subjects who, in the opinion of the investigator, are unable to comply with the requirements of the study or are unsuitable for any reason.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
Dexlansoprazole MR 60 mg QD
Dexlansoprazole MR 90 mg QD
Placebo