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

Tracking Information
First Submitted Date ICMJE	November 22, 2011
First Posted Date ICMJE	November 24, 2011
Last Update Posted Date	April 19, 2012
Study Start Date ICMJE	March 2012
Actual Primary Completion Date	March 2012 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: November 23, 2011)	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.
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; (submitted: November 23, 2011)	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"; 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.; 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)); Mean distal eosinophil number [ Time Frame: 6 weeks ]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	Intervention Model: Single Group Assignment; Masking: None (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 Arms	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
Actual Enrollment ICMJE; (submitted: April 18, 2012)	0
Original Estimated Enrollment ICMJE; (submitted: November 23, 2011)	60
Actual Study Completion Date	March 2012
Actual 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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 80 Years (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Not Provided
Removed Location Countries	United States
Administrative Information
NCT Number ICMJE	NCT01479231
Other Study ID Numbers ICMJE	11-003759
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
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
PRS Account	Mayo Clinic
Verification Date	April 2012
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP