Clinical trial · Interventional
Assessment of Zegerid on Esophageal pH in Patients With Barrett's Esophagus
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): change in the business strategy of the sponsor
Summary
Brief summary (as posted)
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).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Barrett Esophagus | — | UNRESOLVED | — |
| Gastroesophageal Reflux | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bravo pH monitoring | Procedure | — | UNRESOLVED |
| Zegerid (proton pump inhibitor) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Received Zegerid (Ome-NaBic)
- description
- Administered Ome-NaBic 40 mg orally 1 h before breakfast and bedtime
- interventionNames
- Drug: Zegerid (proton pump inhibitor)
- Procedure: Bravo pH monitoring
Primary outcomes (1)
- measure
- Percentage of Time Esophageal pH< 4
- timeFrame
- Days 1 and 2
- description
- 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 outcomes (1)
- measure
- Reflux Disease Questionnaire Score on Day 1 After Therapy Completion
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available