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

Barrett Esophagus research study

What is the primary objective of this study?

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).

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Barrett Esophagus

Gastroesophageal Reflux

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Zegerid (proton pump inhibitor)

Procedure:Bravo pH monitoring

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Received Zegerid (Ome-NaBic)Administered Ome-NaBic 40 mg orally 1 h before breakfast and bedtime

Study Status

Terminated

Start Date: November 2009

Completed Date: December 2010

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Percentage of Time Esophageal pH< 4

Secondary Outcome: Reflux Disease Questionnaire Score on Day 1 After Therapy Completion

Study sponsors, principal investigator, and references

Principal Investigator: Lauren B Gerson

Lead Sponsor: Stanford University

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01129778

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