Open Label Study Evaluating Different Dosing Regimens of Rabeprazole in Gastro-esophageal Reflux Disease (GERD) Patients With Night-time Heartburn Symptoms.

Exclusion Criteria

• •Patients currently taking rabeprazole 20mg once daily (morning or evening administration) or 10mg twice daily (morning and evening administration) on a continuous basis
• •Documented evidence of GERD refractory to acid suppressive therapy (i.e.
• •no or poor clinical response to at least two treatment courses of 4-weeks duration with a PPI)
• •Esophagitis known to be the result of systemic events (e.g. scleroderma, ingested irritants)
• •Active GI bleeding, or presence of "alarm symptoms" (i.e., vomiting, blood in stool, anemia, dysphagia)
• •Documented history of significant pyloric stenosis or esophageal ring stricture
• •Documented evidence of esophageal or gastric varices
• •Patients with primary motility disorders, infectious or inflammatory conditions of the small or large intestine, malabsorption syndromes, GI obstruction, history of gastrointestinal malignancy, definitive acid-lowering surgery or other esophageal, gastric or intestinal surgery (including vagotomy) except for simple closure of perforation
• •Patients who are unable or unwilling to discontinue the use of prostaglandins (e.g. misoprostol), sucralfate, prokinetic agents (e.g. metoclopramide), anticholinergics, cholinergic agents or spasmolytics. Use of opiates may be continued if started at least 2 weeks before study admission and the dosage is consistent (± 25% for total opioid daily dose) throughout the study
• •Treatment with high-dose systemic corticosteroids (\>10mg/day prednisone equivalent) and NSAIDs, including COX-2 selective inhibitors, cannot be initiated at anytime during the study. However, patients taking corticosteroids and NSAIDs (including ASA) before study entry may continue these medications during the study, however, they must have been taking a stable dose (e.g. for oral medication, a consistent daily dose ± 25%) for at least 2 weeks before study admission and the dosage must be kept constant throughout the study. Occasional, intermittent use of NSAIDs for acute, self-limiting conditions (e.g. headache relief) is acceptable during the study
• •\>3 daytime episodes during any 7 consecutive days of the run-in period
• •\>1 severe or very severe daytime episode (i.e., more than 1 daytime heartburn episode rated \>=3) during any 7 consecutive days of the run-in period
• •Maximum total daytime heartburn score \>5 during any 7 consecutive days of the run-in period.