The Role Of Gastroesophageal Reflux Disease (GERD) in Eosinophilic Esophagitis - Full Text View

Sponsor:	Mayo Clinic
Collaborator:	AstraZeneca
Information provided by (Responsible Party):	Amy Foxx-Orenstein, Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00728481

Purpose

This study is being done to see if patients that have eosinophilic esophagitis and gastroesophageal reflux disease (GERD) would receive relief from taking the medication Nexium.

Condition	Intervention	Phase
Eosinophilic Esophagitis	Drug: Nexium Drug: Pulmicort Respules and Splenda	Phase 2 Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	The Role Of Gastroesophageal Reflux Disease (GERD) in Eosinophilic Esophagitis

Resource links provided by NLM:

MedlinePlus related topics: GERD

Drug Information available for: Budesonide Omeprazole Omeprazole magnesium Esomeprazole Esomeprazole Sodium Esomeprazole magnesium

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:

To estimate the proportion of patients with EE that have evidence of GERD. [ Time Frame: 6-12 weeks ] [ Designated as safety issue: No ]

Enrollment:	50
Study Start Date:	May 2008
Study Completion Date:	December 2010
Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 2 Nexium	Drug: Nexium 40 milligrams twice a day
Active Comparator: 1 Pulmicort Respules and Splenda	Drug: Pulmicort Respules and Splenda Pulmicort respules 2 ampules mixed with 1 gram packet of Splenda to be swallowed

Detailed Description:

Hypotheses:

There is a subset of patients with the diagnosis of EE who also have GERD.
Patients with both EE and GERD will respond symptomatically and histologically to aggressive gastric acid suppression with a proton pump inhibitor as monotherapy.
Swallowed budesonide suspension is effective in treating patients with EE who do not have evidence of GERD.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients ages 18-80.
Patients who carry the diagnosis of EE based on esophageal biopsies obtained within 18 months prior to enrollment with greater than 15 eosinophils per hpf (400 X magnification).
Patients who have moderate, severe, or very severe problems swallowing.

Exclusion Criteria:

Patients who are currently being treated for EE.
Patient 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 (PPI 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00728481

Locations

United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905

Sponsors and Collaborators

Mayo Clinic

AstraZeneca

Investigators

Principal Investigator:

Amy Foxx-Orenstein, D.O.

Mayo Clinic

More Information

Additional Information:

Mayo Clinic Clinical Trials This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Amy Foxx-Orenstein, Associate Professor of Medicine, Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00728481 History of Changes
Other Study ID Numbers:	07-006685
Study First Received:	July 15, 2008
Last Updated:	April 27, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Mayo Clinic:

EE

Additional relevant MeSH terms:

Esophagitis
Gastroesophageal Reflux
Eosinophilic Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Esophageal Motility Disorders
Deglutition Disorders
Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

Omeprazole
Budesonide
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids

ClinicalTrials.gov processed this record on May 23, 2012