CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 91 enrolled
Drug / intervention
Omeprazole/sodium bicarbonatedrug
Likely dose
Omeprazole/sodium bicarbonate 40 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00693225
NCT00693225Phase 4Completed
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Impact of Timing on the Efficacy of Omeprazole/Sodium Bicarbonate Zegerid 40 mg in Healing Reflux Esophagitis

Yvonne Romero·interventional·Posted Jun 6, 2008·Updated Sep 20, 2012

In Brief

A Phase 4 clinical trial evaluating Omeprazole/sodium bicarbonate for Erosive Esophagitis. Completed, enrolled 91 participants across 1 site.

Detailed Summary

The purpose of this study was to determine the effect of morning versus bedtime administration of omeprazole/sodium bicarbonate (Zegerid) on endoscopic healing for patients with moderate or severe reflux esophagitis. Our hypothesis was that bedtime administration of Zegerid would be superior in healing esophagitis compared to morning administration prior to a meal.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsErosive Esophagitis
CountriesUnited States
CollaboratorsBausch Health Americas, Inc.

Timeline

Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 6, 2008
Enrollment StartJan 1, 2008
Primary CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 18.1 years ago

Interventions

Omeprazole/sodium bicarbonatedrug

Omeprazole/sodium bicarbonate powder for oral suspension 40 mg was supplied in individual packets that were emptied into a small cup containing 15-30 ml (1-2 tablespoons) of water, one per day, for 8 weeks.