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

This study has been withdrawn prior to enrollment.

(Souces of funding have been terminated)

Sponsor:

Information provided by (Responsible Party):

Jeffrey A Alexander, Mayo Clinic

ClinicalTrials.gov Identifier:

NCT01479231

First received: November 22, 2011

Last updated: April 18, 2012

Last verified: April 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

November 22, 2011

Last Updated Date

April 18, 2012

Start Date ^ICMJE

March 2012

Primary Completion Date

March 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Prevalence of Gastroesophageal Reflux Disease [ Time Frame: 24 hour ] [ Designated as safety issue: Yes ]

Prevalence of Gastroesophageal Reflux Disease (GERD) in Eosinophilic Esophagitis (EoE) Description: The definition of GERD is acid exposure time of >4.2% over 24 hour period, as measured by pH monitoring.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01479231 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Heartburn/regurgitation [ Time Frame: 30 day ] [ Designated as safety issue: Yes ]
Heartburn/regurgitation (as measured by:) Mayo Dysphagia Questionnaire - 30 Day Validated 28 item instrument; 0 = no dysphagia, higher levels indicate greater dysphagia severity. Dysphagia. 2010 Sep;25(3):221-30 Measured by "units on a scale"
Abnormal 24 hour acid exposure [ Time Frame: 24 hour ] [ Designated as safety issue: Yes ]
Abnormal 24 hour acid exposure (as measured by pH monitoring) Description: A thin plastic catheter is passed through one nostril, down the back of the throat, and into the esophagus as the patient swallows. The tip of the catheter contains a sensor that senses acid. The catheter protruding from the nose is connected to a recorder that registers each reflux of acid. The catheter is in place for 24 hours, when is removed and the recorder is attached to a computer so that the data can be downloaded.
Ratio of distal/proximal mean esophageal eosinophil number [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
Ratio of distal/proximal mean esophageal eosinophil number (as measured by biopsies taken during esophagogastroduodenoscopy (EGD))
Mean distal eosinophil number [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
Mean distal eosinophil number (as measured by biopsies taken during esophagogastroduodenoscopy (EGD) )

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Predictors of PPI Response in Eosinophilic Esophagitis

Brief Summary

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

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Gastroesophageal Reflux Disease
Eosinophilic Esophagitis
Dysphagia

Intervention ^ICMJE

Drug: dexlansoprazole

Dexlansoprazole 60 mg daily for 6 weeks

Other Name: Dexilant

Study Arm (s)

Experimental: dexlansoprazole

Intervention: Drug: dexlansoprazole

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Withdrawn

Enrollment ^ICMJE

Completion Date

March 2012

Primary Completion Date

March 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Not Provided

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01479231

Other Study ID Numbers ^ICMJE

11-003759

Has Data Monitoring Committee

Yes

Responsible Party

Jeffrey A Alexander, Mayo Clinic

Study Sponsor ^ICMJE

Mayo Clinic

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Jeffrey A Alexander, MD

Mayo Clinic

Information Provided By

Mayo Clinic

Verification Date

April 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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