Assessment of Zegerid on Esophageal pH in Patients With Barrett's Esophagus

• Status: Terminated
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this research study is to assess how safe, effective (how well it works), and tolerable (to put up with) the drug Zegerid is in reducing reflux episodes in patients who have both gastroesophageal reflux disease (GERD) and Barrett's esophagus. Zegerid has been approved by the US Food and Drug Administration (FDA) for the treatment of GERD. The investigators hope to learn the effectiveness of Zegerid for reducing the amount of acid reflux patients are experiencing in the esophagus (swallowing pipe).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University
• Treatments: Omeprazole; Omeprazole, sodium bicarbonate drug combination; Proton Pump Inhibitors

Criteria

Inclusion Criteria:

• Inclusion criteria include adult men and women (aged <=18 years) with previously established, biopsy-proven diagnosis of BE (any length intestinal metaplasia without dysplasia or adenocarcinoma)

Exclusion Criteria:

• Exclusion criteria include a history of esophageal, gastric, or duodenal surgery (including antireflux surgery or endoscopic antireflux procedures), except for simple ulcer closure

• Zollinger-Ellison syndrome

• Endoscopic evidence or suspicion of a pathologic or infiltrative process in the stomach

• Positive for H. pylori.