CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 51 enrolled
Drug / intervention
Esomeprazole +1 moredrug
Likely dose
Esomeprazole 40mgfrom 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/NCT00728481
NCT00728481Phase 3Completed
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The Role Of Gastroesophageal Reflux Disease (GERD) in Eosinophilic Esophagitis

Mayo Clinic·interventional·Posted Aug 5, 2008·Updated Jan 14, 2016

In Brief

A Phase 3 clinical trial evaluating Esomeprazole and Budesonide for Eosinophilic Esophagitis and 3 related conditions. Completed, enrolled 51 participants across 1 site.

Detailed Summary

The primary aim of this study was to determine the proportion of patients with esophageal eosinophilic infiltration that have objective (measurable) evidence of gastroesophageal reflux disease (GERD). This study was also done to see if patients that have eosinophilic esophagitis (EE) and GERD would receive relief from taking the medication Nexium or a steroid called Pulmicort. The study also evaluated the accuracy of pH monitoring (acid exposure) within the esophagus as a predictor of endoscopic, histological and symptomatic response in patients with EE.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEosinophilic Esophagitis, Gastroesophageal Reflux Disease, EE, GERD
CountriesUnited States
CollaboratorsAstraZeneca

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 5, 2008
Enrollment StartMay 1, 2008
Primary CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 17.9 years ago

Interventions

Esomeprazoledrug

Proton pump inhibitor; Nexium 40mg capsule taken twice daily by mouth for 6 weeks

Budesonidedrug

Corticosteroid therapy; oral viscous Pulmicort Respules 1 gram taken by mouth orally twice daily (mixed with 1 gram packet of Sucralose \[Splenda-registered trademark\]) for 6 weeks in subjects with negative 24 hour pH studies (without GERD)