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Impact of Timing on the Efficacy of Zegerid 40 mg in Healing Reflux Esophagitis: A Pilot Study

NCT00693225 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 91

Last updated 2012-09-20

Study results available
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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.

Conditions

  • Erosive Esophagitis

Interventions

DRUG

Omeprazole/sodium bicarbonate

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.

Sponsors & Collaborators

  • Bausch Health Americas, Inc.

    collaborator INDUSTRY

  • Yvonne Romero

    lead OTHER

Principal Investigators

  • Yvonne Romero, M.D. · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00693225 on ClinicalTrials.gov