Safety and Efficacy of Dexlansoprazole Modified Release Formulation to Treat Heartburn

This is a Phase 3, randomized, double-blind, multi-center, placebo-controlled, 3-arm study with a 4 week treatment period. This study will compare the efficacy of daily Dexlansoprazole MR (60 mg and 90 mg) with that of placebo when administered orally as a single daily dose in the morning, before breakfast. The study is designed to evaluate symptom relief in subjects with symptomatic non-erosive GERD. Approximately 450 subjects will be enrolled at approximately 120 U.S. and potentially ex U.S. sites. The study consists of two periods; a Screening Period, which will last a minimum of 7 days and a maximum of 21 days, and a treatment period, which will last 4 weeks.

Because the development plan for Dexlansoprazole MR was revised, the results of 2 identical studies, T-GD04-082 (NCT00241745) and T-GD04-083 (this posting, NCT00251758), were combined and analyzed as a single larger study, referred to as study T-GD04-082. A total of 908 subjects were included in the combined analysis; 416 subjects were enrolled into Study T-GD04-082 and 492 subjects were enrolled into Study T-GD04-083.

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
• 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
• 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
• Subjects who, in the opinion of the investigator, are unable to comply with the requirements of the study or are unsuitable for any reason.
• Acute upper gastrointestinal (UGI) hemorrhage within 4 weeks of the Screening endoscopy