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Proton Pump Inhibitor

Received Zegerid (Ome-NaBic) for Barrett's Esophagus

N/A
Waitlist Available
Led By Lauren B Gerson
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 1 and 2
Awards & highlights

Study 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).

Eligible Conditions
  • Barrett's Esophagus
  • Acid Reflux

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 1 and 2
This trial's timeline: 3 weeks for screening, Varies for treatment, and days 1 and 2 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Time Esophageal pH< 4
Secondary outcome measures
Reflux Disease Questionnaire Score on Day 1 After Therapy Completion

Trial Design

1Treatment groups
Experimental Treatment
Group I: Received Zegerid (Ome-NaBic)Experimental Treatment2 Interventions
Administered Ome-NaBic 40 mg orally 1 h before breakfast and bedtime

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Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,410 Previous Clinical Trials
17,343,364 Total Patients Enrolled
Lauren B GersonPrincipal InvestigatorStanford University
~2 spots leftby Jul 2025
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