Predictors of Proton Pump Inhibitor (PPI) Response in Eosinophilic Esophagitis

NCT ID: NCT01479231

Last Updated: 2012-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2012-03-31

Brief Summary

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The investigators will determine the prevalence of gastroesophageal reflux disease (GERD) in Eosinophilic Esophagitis (EoE) and importantly determine the predictors of response to Proton Pump Inhibitor (PPI) therapy in EoE. Moreover, the investigators will determine the effect of GERD on the location of esophageal eosinophilia.

Detailed Description

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Conditions

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Gastroesophageal Reflux Disease Eosinophilic Esophagitis Dysphagia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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dexlansoprazole

Group Type EXPERIMENTAL

dexlansoprazole

Intervention Type DRUG

Dexlansoprazole 60 mg daily for 6 weeks

Interventions

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dexlansoprazole

Dexlansoprazole 60 mg daily for 6 weeks

Intervention Type DRUG

Other Intervention Names

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Dexilant

Eligibility Criteria

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Inclusion Criteria

* 18 years of age \< 80 years of age
* 14 eosinophils / hpf on biopsies from esophagus

* Abnormal validated Mayo dysphagia questionnaire (MDQ-30) (question 2"yes", question 4 \> "moderate" and question 7 \> "once a week")
* Clinically performed EGD with \> 14 eosinophils/hpf completed within last 3 months

Exclusion Criteria

* Other cause of dysphagia identified at endoscopy (e.g. stricture, web, infection, ring, achalasia, esophageal neoplasm)
* Dilatation of esophagus at time of index endoscopy
* Treatment with topical steroid within 3 months of index endoscopy
* Treatment with PPI in last 30 days prior to index EGD

Patient population - adults with EoE recruited from Mayo Clinic Rochester, MN patient population
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Jeffrey A Alexander

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jeffrey A Alexander, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Other Identifiers

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11-003759

Identifier Type: -

Identifier Source: org_study_id

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