Local Phase IV, Gastroesophageal Reflux Disease (GERD) Sleep Study US

Inclusion Criteria:

• Prior to the run-in period, a history of heartburn or acid regurgitation for 3 months or longer or any history of EE;
• Prior to the run-in period, nighttime heartburn averaging at least 2 or 3 times per week;
• Prior to the run-in period, a history of sleep disturbances associated with GERD for 1 month or more;

Exclusion Criteria:

• Any condition other than GERD that is either the primary cause of, or a significant contributor to, the patient's sleep disturbance
• Sleep medication (including over-the-counter), antihistamine, benzodiazepine, or anti-anxiety medication use that has not been stable (either in dose or regularity) for at least 3 months or is not expected to remain stable during the patient's participation in the study. Patients on a stable regimen, whose regimen is also expected to remain stable throughout the study, are eligible for participation;
• Proton Pump Inhibitor (PPI) use within 1 week prior to Screening. The only allowable acid modifying rescue medication is GELUSIL® during the run-in period. Only study medication and rescue medication (GELUSIL®) is allowed during the treatment period for treatment of acid mediated symptoms