Maintenance Intermittent Therapy for Symptomatic GERD Patients

Exclusion Criteria

• •1. Evidence of significant hepatic, renal, respiratory, endocrine, hematologic, neurologic, psychiatric or cardiovascular system abnormalities, unless the Sponsor and Investigator agree that the nature and severity of any abnormality is unlikely to interfere with the conduct of the study, the interpretation of study results, or the health of the patient during the study.
• •2. Females must not be pregnant, lactating or have a positive urine eta human chorionic gonadotropin (B-hCG) laboratory result.
• •3. Patients with a history of allergy or sensitivity to proton pump inhibitors or to their inactive ingredients.
• •4. Patients with known gastric ulcer, duodenal ulcer, infectious or inflammatory conditions of the small or large intestine, malabsorption syndromes, obstruction, a history of gastrointestinal malignancy, or prior gastric or intestinal surgery (including vagotomy).
• •5. Patients who have a history of Barrett's esophagus, esophageal stricture, or pyloric stenosis.
• •6. Patients with a history of endoscopically-proven esophagitis any time in the past.
• •7. Patients who have taken proton pump inhibitors (PPIs, prescription or OTC), H2 blockers (prescription or OTC) or prokinetics within 14 days, prior to Screening endoscopy, or any of these medications within 7 days prior to the single-blind placebo run-in period.