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The Role Of Gastroesophageal Reflux Disease (GERD) in Eosinophilic Esophagitis

NCT00728481 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2016-01-14

Study results available
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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.

Conditions

  • Eosinophilic Esophagitis
  • Gastroesophageal Reflux Disease
  • EE
  • GERD

Interventions

DRUG

Esomeprazole

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

DRUG

Budesonide

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)

Sponsors & Collaborators

Principal Investigators

  • Amy Foxx-Orenstein, D.O. · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT00728481 on ClinicalTrials.gov