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Recruitment Status : Withdrawn (Souces of funding have been terminated)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|
|Actual Primary Completion Date :||March 2012|
|Actual 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) )
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01479231
|Principal Investigator:||Jeffrey A Alexander, MD||Mayo Clinic|