Back to resultsPredictors of Proton Pump Inhibitor (PPI) Response in Eosinophilic Esophagitis
Primary Purpose
Gastroesophageal Reflux Disease, Eosinophilic Esophagitis, Dysphagia
Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
dexlansoprazole
Sponsored by
About this trial
This is an interventional treatment trial for Gastroesophageal Reflux Disease focused on measuring GERD, Eosinophilic esophagitis, Proton pump inhibitor, dysphagia
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
dexlansoprazole
Arm Description
Outcomes
Primary Outcome Measures
Prevalence of Gastroesophageal Reflux Disease
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
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
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
Ratio of distal/proximal mean esophageal eosinophil number (as measured by biopsies taken during esophagogastroduodenoscopy (EGD))
Mean distal eosinophil number
Mean distal eosinophil number (as measured by biopsies taken during esophagogastroduodenoscopy (EGD) )
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01479231
Brief Title
Predictors of Proton Pump Inhibitor (PPI) Response in Eosinophilic Esophagitis
Official Title
Predictors of PPI Response in Eosinophilic Esophagitis
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Withdrawn
Why Stopped
Souces of funding have been terminated
Study Start Date
March 2012 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux Disease, Eosinophilic Esophagitis, Dysphagia
Keywords
GERD, Eosinophilic esophagitis, Proton pump inhibitor, dysphagia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
dexlansoprazole
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
dexlansoprazole
Other Intervention Name(s)
Dexilant
Intervention Description
Dexlansoprazole 60 mg daily for 6 weeks
Primary Outcome Measure Information:
Title
Prevalence of Gastroesophageal Reflux Disease
Description
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.
Time Frame
24 hour
Secondary Outcome Measure Information:
Title
Heartburn/regurgitation
Description
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"
Time Frame
30 day
Title
Abnormal 24 hour acid exposure
Description
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.
Time Frame
24 hour
Title
Ratio of distal/proximal mean esophageal eosinophil number
Description
Ratio of distal/proximal mean esophageal eosinophil number (as measured by biopsies taken during esophagogastroduodenoscopy (EGD))
Time Frame
6 weeks
Title
Mean distal eosinophil number
Description
Mean distal eosinophil number (as measured by biopsies taken during esophagogastroduodenoscopy (EGD) )
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey A Alexander, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Predictors of Proton Pump Inhibitor (PPI) Response in Eosinophilic Esophagitis
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