Clinical trial NCT01129778: Assessment of Zegerid on Esophageal pH in Patients With Barrett's Esophagus
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Barrett Esophagus
Gastroesophageal Reflux
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2010-05-25
Enrollment: 27
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Percentage of Time Esophageal pH< 4
timeFrame: Days 1 and 2
Secondary outcomes:
measure: Reflux Disease Questionnaire Score on Day 1 After Therapy Completion
timeFrame: Day 1 after therapy period completion
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Lauren B Gerson
role: PRINCIPAL_INVESTIGATOR
References: