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

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Efficacy Study Comparing 4 Weeks of Treatment With Esomeprazole 20 mg qd to Placebo qd in Patients With Heartburn and Sleep Disturbances Associated With Gastroesophageal Reflux Disease (GERD)

The purpose of this research study is to compare the safety and effectiveness (how well the medicine works) of esomeprazole (study drug) to placebo (a capsule that does not contain any medication) taken daily in relieving nighttime heartburn and problems sleeping in patients with gastroesophageal reflux disease (GERD).

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