Barrett Esophagus, Gastroesophageal Reflux
Conditions
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.
Interventions
DRUGZegerid (proton pump inhibitor)
PROCEDUREBravo pH monitoring
Sponsors
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Time Esophageal pH< 4 | Days 1 and 2 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reflux Disease Questionnaire Score on Day 1 After Therapy Completion | Day 1 after therapy period 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. |
Countries
United States
Participant flow
Pre-assignment details
5 participants withdrew after providing their informed consent and before beginning their participation in the study.
Participants by arm
| Arm | Count |
|---|---|
| Received Zegerid (Ome-NaBic) Ome-NaBic 40 mg orally 1 h before breakfast and bedtime for up to 29 days | 21 |
| Total | 21 |
Baseline characteristics
| Characteristic | Received Zegerid (Ome-NaBic) |
|---|---|
| Age, Continuous | 61 years STANDARD_DEVIATION 10 |
| Mean RDQ heartburn score | 10 units on a scale STANDARD_DEVIATION 6 |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 22 |
| serious Total, serious adverse events | 0 / 22 |
Outcome results
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.
Time frame: Days 1 and 2
Population: Participants who completed all protocol-specified assessments were included in the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Received Zegerid (Ome-NaBic) | Percentage of Time Esophageal pH< 4 | Total time pH <4 First Day | 0.4 percentage of hours | Standard Deviation 0.5 |
| Received Zegerid (Ome-NaBic) | Percentage of Time Esophageal pH< 4 | Total time pH <4 Second Day | 0.6 percentage of hours | Standard Deviation 1.8 |
| Received Zegerid (Ome-NaBic) | Percentage of Time Esophageal pH< 4 | Upright time pH <4 First Day | 0.7 percentage of hours | Standard Deviation 0.7 |
| Received Zegerid (Ome-NaBic) | Percentage of Time Esophageal pH< 4 | Upright time pH <4 Second Day | 1 percentage of hours | Standard Deviation 3 |
| Received Zegerid (Ome-NaBic) | Percentage of Time Esophageal pH< 4 | Supine time pH <4 First Day | 0.06 percentage of hours | Standard Deviation 0.1 |
| Received Zegerid (Ome-NaBic) | Percentage of Time Esophageal pH< 4 | Supine time pH <4 Second Day | 0.05 percentage of hours | Standard Deviation 0.2 |
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.
Time frame: Day 1 after therapy period completion
Population: Participants who completed all protocol-specified assessments were included in the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Received Zegerid (Ome-NaBic) | Reflux Disease Questionnaire Score on Day 1 After Therapy Completion | 0.5 Units on a scale | Standard Deviation 1.5 |