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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This study has been withdrawn prior to enrollment.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
  Purpose

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.


Condition Intervention Phase
Gastroesophageal Reflux Disease
Eosinophilic Esophagitis
Dysphagia
 Drug: dexlansoprazole
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Predictors of PPI Response in Eosinophilic Esophagitis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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) )


Enrollment: 0
Study Start Date: March 2012
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: dexlansoprazole Drug: dexlansoprazole
Dexlansoprazole 60 mg daily for 6 weeks
Other Name: Dexilant

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01479231

Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Jeffrey A Alexander, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Jeffrey A Alexander, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01479231     History of Changes
Other Study ID Numbers: 11-003759
Study First Received: November 22, 2011
Last Updated: April 18, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
GERD
Eosinophilic esophagitis
Proton pump inhibitor
dysphagia

Additional relevant MeSH terms:
Deglutition Disorders
Esophagitis
Gastroesophageal Reflux
Eosinophilic Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases
Gastroenteritis
Esophageal Motility Disorders
Eosinophilia
Leukocyte Disorders
 Hematologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Lansoprazole
Proton Pump Inhibitors
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 21, 2013