- Confirmed symptom history of heartburn, acid regurgitation, or epigastric pain of at
least 3 months, while treating with gastric acid modulating therapy (antacids, H2
receptor antagonists (H2RAs) and/or PPIs).
- Heartburn symptoms that average 3 times per week or greater including at least 2
episodes of nighttime heartburn symptoms per week over the past 30 days.
- When heartburn medications were used, subject had heartburn symptoms that were
responsive to antacids, non prescription H2RAs, or short term non prescription or
prescription PPIs at approved doses but complete resolution of heartburn was not
achieved.
- A history (past or present) of erosive esophagitis verified by endoscopy.
- The need for continuous treatment with H2RAs, PPIs, gastric prokinetic drugs, or
antacids for any indication through the study (eg, long term prescription therapy).
- Subjects requiring continuous intervention by a physician for the treatment of GERD
(ie, treatment of erosive esophagitis or prevention of relapse of healed esophagitis).