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

This study has been withdrawn prior to enrollment.
(Souces of funding have been terminated)
Sponsor:
Information provided by (Responsible Party):
Jeffrey A Alexander, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01479231
First received: November 22, 2011
Last updated: April 18, 2012
Last verified: April 2012

November 22, 2011
April 18, 2012
March 2012
March 2012   (final data collection date for primary outcome measure)
Prevalence of Gastroesophageal Reflux Disease [ Time Frame: 24 hour ] [ Designated as safety issue: Yes ]
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.
Same as current
Complete list of historical versions of study NCT01479231 on ClinicalTrials.gov Archive Site
  • Heartburn/regurgitation [ Time Frame: 30 day ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Ratio of distal/proximal mean esophageal eosinophil number (as measured by biopsies taken during esophagogastroduodenoscopy (EGD))
  • Mean distal eosinophil number [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    Mean distal eosinophil number (as measured by biopsies taken during esophagogastroduodenoscopy (EGD) )
Same as current
Not Provided
Not Provided
 
Predictors of Proton Pump Inhibitor (PPI) Response in Eosinophilic Esophagitis
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.

Not Provided
Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Gastroesophageal Reflux Disease
  • Eosinophilic Esophagitis
  • Dysphagia
Drug: dexlansoprazole
Dexlansoprazole 60 mg daily for 6 weeks
Other Name: Dexilant
Experimental: dexlansoprazole
Intervention: Drug: dexlansoprazole
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
March 2012
March 2012   (final data collection date for primary outcome measure)

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

Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01479231
11-003759
Yes
Jeffrey A Alexander, Mayo Clinic
Mayo Clinic
Not Provided
Principal Investigator: Jeffrey A Alexander, MD Mayo Clinic
Mayo Clinic
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP