Status:
COMPLETED
The Role Of Gastroesophageal Reflux Disease (GERD) in Eosinophilic Esophagitis
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
AstraZeneca
Conditions:
Eosinophilic Esophagitis
Gastroesophageal Reflux Disease
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
PHASE3
Brief Summary
The primary aim of this study was to determine the proportion of patients with esophageal eosinophilic infiltration that have objective (measurable) evidence of gastroesophageal reflux disease (GERD)....
Detailed Description
Hypotheses: 1. There is a subset of patients with the diagnosis of EE who also have GERD. 2. Patients with both EE and GERD will respond symptomatically and histologically to aggressive gastric acid ...
Eligibility Criteria
Inclusion
- Patients ages 18-80.
- Patients who carry the diagnosis of Eosinophilic Esophagitis (EE) based on esophageal biopsies obtained within 18 months prior to enrollment with greater than 15 eosinophils (eos) per high power field (hpf) (400 X magnification).
- Patients who have moderate, severe, or very severe problems swallowing.
Exclusion
- Patients who are currently being treated for EE.
- Patients who have used topical or systemic corticosteroid therapy for any reason over the past 4 weeks.
- Patients who have been treated with acid-suppressing medications (Proton Pump Inhibitor or H2 receptor antagonists) within 4 weeks prior to enrollment.
- Patients with known allergies or hypersensitivity to proton-pump inhibitors or corticosteroids.
- Patients who have contraindications to the procurement of biopsies including patients how have known bleeding disorders, a history of bleeding diathesis, or who are currently using warfarin or clopidogrel.
- Patients who have a contraindication to the performance of an esophagogastroduodenoscopy (EGD) including previous cardiopulmonary arrest during an endoscopic procedure.
- Patients who have contraindications to the performance of ambulatory impedance 24-hour pH testing including patients with oropharyngeal abnormalities that would prohibit the safe passage of the transnasal catheter and patients who are currently using warfarin, have a history of bleeding disorders or bleeding diatheses.
- Patients who are pregnant.
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT00728481
Start Date
May 1 2008
End Date
December 1 2010
Last Update
January 14 2016
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905