- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01479231
Predictors of Proton Pump Inhibitor (PPI) Response in Eosinophilic Esophagitis
April 18, 2012 updated by: Jeffrey A Alexander, Mayo Clinic
Predictors of PPI Response in Eosinophilic Esophagitis
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.
Study Overview
Status
Withdrawn
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 2
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: dexlansoprazole
|
Dexlansoprazole 60 mg daily for 6 weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prevalence of Gastroesophageal Reflux Disease
Time Frame: 24 hour
|
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.
|
24 hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Heartburn/regurgitation
Time Frame: 30 day
|
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"
|
30 day
|
Abnormal 24 hour acid exposure
Time Frame: 24 hour
|
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.
|
24 hour
|
Ratio of distal/proximal mean esophageal eosinophil number
Time Frame: 6 weeks
|
Ratio of distal/proximal mean esophageal eosinophil number (as measured by biopsies taken during esophagogastroduodenoscopy (EGD))
|
6 weeks
|
Mean distal eosinophil number
Time Frame: 6 weeks
|
Mean distal eosinophil number (as measured by biopsies taken during esophagogastroduodenoscopy (EGD) )
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jeffrey A Alexander, MD, Mayo Clinic
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2012
Primary Completion (Actual)
March 1, 2012
Study Completion (Actual)
March 1, 2012
Study Registration Dates
First Submitted
November 22, 2011
First Submitted That Met QC Criteria
November 23, 2011
First Posted (Estimate)
November 24, 2011
Study Record Updates
Last Update Posted (Estimate)
April 19, 2012
Last Update Submitted That Met QC Criteria
April 18, 2012
Last Verified
April 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Immune System Diseases
- Hypersensitivity, Immediate
- Hematologic Diseases
- Gastrointestinal Diseases
- Gastroenteritis
- Pharyngeal Diseases
- Otorhinolaryngologic Diseases
- Hypersensitivity
- Esophageal Motility Disorders
- Esophageal Diseases
- Leukocyte Disorders
- Eosinophilia
- Gastroesophageal Reflux
- Deglutition Disorders
- Eosinophilic Esophagitis
- Esophagitis
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Gastrointestinal Agents
- Anti-Ulcer Agents
- Proton Pump Inhibitors
- Dexlansoprazole
- Lansoprazole
Other Study ID Numbers
- 11-003759
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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