Predictors of Proton Pump Inhibitor (PPI) Response in Eosinophilic Esophagitis
|ClinicalTrials.gov Identifier: NCT01479231|
Recruitment Status : Withdrawn (Souces of funding have been terminated)
First Posted : November 24, 2011
Last Update Posted : April 19, 2012
|Condition or disease||Intervention/treatment||Phase|
|Gastroesophageal Reflux Disease Eosinophilic Esophagitis Dysphagia||Drug: dexlansoprazole||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Predictors of PPI Response in Eosinophilic Esophagitis|
|Study Start Date :||March 2012|
|Primary Completion Date :||March 2012|
|Study Completion Date :||March 2012|
Dexlansoprazole 60 mg daily for 6 weeks
Other Name: Dexilant
- 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.
- 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) )
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01479231
|Principal Investigator:||Jeffrey A Alexander, MD||Mayo Clinic|