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

NCT ID: NCT01129778

Last Updated: 2017-06-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2010-12-31

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.

Conditions

Barrett Esophagus; Gastroesophageal Reflux

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Received Zegerid (Ome-NaBic)

Administered Ome-NaBic 40 mg orally 1 h before breakfast and bedtime

Group Type: EXPERIMENTAL

Zegerid (proton pump inhibitor)

Intervention Type: DRUG

Bravo pH monitoring

Intervention Type: PROCEDURE

Interventions

Zegerid (proton pump inhibitor)

Intervention Type: DRUG

Bravo pH monitoring

Intervention Type: PROCEDURE

Other Intervention Names

Omeprazole-sodium bicarbonate (Ome-NaBic)

Eligibility Criteria

Exclusion Criteria

• Zollinger-Ellison syndrome
• Endoscopic evidence or suspicion of a pathologic or infiltrative process in the stomach
• Positive for H. pylori.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lauren B Gerson

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University School of Medicine

Stanford, California, United States

Countries

United States

Related Links

http://onlinelibrary.wiley.com/doi/10.1111/j.1365-2036.2012.05016.x/full

Link to publication about this study

Other Identifiers

SU-04302010-5803

Identifier Type: -

Identifier Source: org_study_id