Barrett EsophagusNCT01129778
Assessment of Zegerid on Esophageal pH in Patients With Barrett's Esophagus
A study testing Zegerid (proton pump inhibitor) and Bravo pH monitoring in people with Barrett Esophagus and Gastroesophageal Reflux, run by Stanford University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Barrett Esophagus, Gastroesophageal Reflux
- What is being tested?
- Zegerid (proton pump inhibitor) and Bravo pH monitoring
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Dec 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this 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
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).
Read the 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
- Being tested
- Zegerid (proton pump inhibitor), Bravo pH monitoring
- Medical subject headings
- Barrett Esophagus, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zegerid (proton pump inhibitor)Drug
Also called Omeprazole-sodium bicarbonate (Ome-NaBic)
Bravo pH monitoringProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Received Zegerid (Ome-NaBic) | Experimental | Administered Ome-NaBic 40 mg orally 1 h before breakfast and bedtime Receives: Drug: Zegerid (proton pump inhibitor); Procedure: Bravo pH monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Days 1 and 2
Secondary outcomes (1)
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.
Measured: Day 1 after therapy period completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2010 (estimated)
- Study startNov 2009
- Primary completionJul 2010
- Study completionDec 2010
Why it stopped: change in the business strategy of the sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Barrett EsophagusStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lauren B Gerson, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01129778
- Sponsor's protocol ID
- SU-04302010-5803
- Status last verified
- Jun 2017
- First submitted
- 21 May 2010
- Last updated
- 6 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01129778
- Acronym / sponsor ID
- SU-04302010-5803
- Conditions
- Barrett Esophagus, Gastroesophageal Reflux
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: change in the business strategy of the sponsor
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 25 May 2010 (estimated)
- Results
- Posted 6 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Received Zegerid (Ome-NaBic) | Experimental | Drug: Zegerid (proton pump inhibitor), Procedure: Bravo pH monitoringAdministered Ome-NaBic 40 mg orally 1 h before breakfast and bedtime |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zegerid (proton pump inhibitor)Also: Omeprazole-sodium bicarbonate (Ome-NaBic) | Drug | Received Zegerid (Ome-NaBic) |
| Bravo pH monitoring | Procedure or surgery | Received Zegerid (Ome-NaBic) |
Primary outcome
Percentage of Time Esophageal pH< 4
Time frame: 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.
1 secondary outcome
Reflux Disease Questionnaire Score on Day 1 After Therapy Completion
Time frame: Day 1 after therapy period completion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Link to publication about this studyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lauren B Gerson principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zegerid (proton pump inhibitor) and Bravo pH monitoring in people with Barrett Esophagus and Gastroesophageal Reflux, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Time Esophageal pH< 4 (time frame: Days 1 and 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2017.