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

Study Overview
=================
Brief 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).

Detailed Description
-----------------
The following procedures will be performed at the Screening Visit: Obtain informed consent. Obtain information about your age and gender. Evaluate whether you qualify for the study. Document prior negative testing for H. pylori infection (a bacterial infection in the stomach that can cause ulcers) including the date of testing. Make sure that you have not used any investigational medications or participated in a clinical trial in the 30 days prior to the Screening Visit. Obtain medical history. Record medication history (including concomitant medications). Obtain vital signs. Conduct a physical examination. If a Bravo pH study has not been done within 8 weeks, instruct the patient to discontinue their medication for GERD during the 7-10 day washout period. Instruct the patient to discontinue the use of all prohibited medications during the applicable time intervals and not to start any new concomitant medications during the trial. Distribute Gelusil tablets to be used as rescue medication; instruct the patient that no more than 6 Gelusil tablets per day or 21 tablets over any 7-day interval will be allowed. Schedule the patient to return for the Qualification Visit, or for pH monitoring and the Qualification Visit. Only patients with abnormal pH monitoring will be able to enter the treatment period. Procedures that will occur during the Treatment Period: You will receive Zegerid 1 hour before breakfast and at bedtime for at least 14 days and no longer than 28 days At the end of the Zegerid treatment period, you will undergo 48-hour Bravo pH monitoring on Zegerid therapy for two days. You will complete a symptom survey and quality of life survey after the completion of the pH study.

Official Title
-----------------
Assessment of the Effects of Zegerid Powder for Oral Suspension 40 mg on 24-Hour and Nocturnal Esophageal Acid Exposure in Patients With Gastroesophageal Reflux Disease and Barrett's Esophagus

Conditions
-----------------
Barrett Esophagus, Gastroesophageal Reflux

Intervention / Treatment
-----------------
* Drug: Zegerid (proton pump inhibitor)
* Procedure: Bravo pH monitoring


Participation Criteria
=================
Eligibility 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.
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Received Zegerid (Ome-NaBic)<br>Administered Ome-NaBic 40 mg orally 1 h before breakfast and bedtime | Drug: Zegerid (proton pump inhibitor)<br> <br> * Other names: Omeprazole-sodium bicarbonate (Ome-NaBic);Procedure: Bravo pH monitoring<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Time Esophageal pH< 4 | Reported as the the average percentage over 24 hours of total time, upright time, and supine time per day with pH <4 (symptomatic acid state) as evaluated with the Bravo pH monitoring technique. | Days 1 and 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reflux Disease Questionnaire Score on Day 1 After Therapy Completion | The RDQ is a 12 item survey that asks the patient to rate the frequency and severity of GERD symptoms. Each item is scored from 0 to 5 where a score of 0 is equivalent to an asymptomatic state and 5 indicates the worst severity of GERD symptoms. The total RDQ is a sum of all 12 items, and can range from 0 to 60. | Day 1 after therapy period completion |