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

Gastroesophageal Reflux Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01129778
• Other study ID #: SU-04302010-5803
• Status: Terminated
• Phase: N/A
• First received: May 21, 2010
• Last updated: June 2, 2017
• Start date: November 2009
• Est. completion date: December 2010

Study information

• Verified date: June 2017
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 27
• Est. completion date: December 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Barrett Esophagus
• Gastroesophageal Reflux

Intervention

Drug:
• Zegerid (proton pump inhibitor)

Procedure:
• Bravo pH monitoring

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

•   Link to publication about this study