Who is sponsoring NCT00728481?

NCT00728481 is sponsored by Mayo Clinic.

What condition does NCT00728481 study?

NCT00728481 studies Eosinophilic Esophagitis, Gastroesophageal Reflux Disease, EE, GERD.

What drugs are being tested in NCT00728481?

Interventions: Esomeprazole, Budesonide.

What is the status of NCT00728481?

NCT00728481 is currently COMPLETED.

Last reviewed 2016-01-12 · How we verify

The Role Of Gastroesophageal Reflux Disease (GERD) in Eosinophilic Esophagitis

NCT00728481 Phase 2/Phase 3 COMPLETED Results posted

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). This study was also done to see if patients that have eosinophilic esophagitis (EE) and GERD would receive relief from taking the medication Nexium or a steroid called Pulmicort. The study also evaluated the accuracy of pH monitoring (acid exposure) within the esophagus as a predictor of endoscopic, histological and symptomatic response in patients with EE.

Details

Lead sponsor	Mayo Clinic
Phase	Phase 2/Phase 3
Status	COMPLETED
Enrolment	51
Start date	2008-05
Completion	2010-12

Conditions

Eosinophilic Esophagitis
Gastroesophageal Reflux Disease
EE
GERD

Interventions

Esomeprazole
Budesonide

Primary outcomes

Histological Response to Treatment — Baseline, 6 months
Subjects with Esophageal eosinophilia experiencing a histological response to treatment. Subjects were considered to have histological response to treatment if both sets of biopsies (from the distal and mid-esophagus) had, on average, less than 5 eosinophils per high power field (eos/hpf) at the 6-month biopsies.
Symptomatic Response to Treatment — Baseline, 6 months
Subjects with Esophageal eosinophilia experiencing a response in their dysphagia symptoms to treatment. Symptomatic improvement in symptoms was defined as a score of at least two levels lower than the baseline dysphagia symptom question on the Mayo Dysphagia Questionnaire-30 days (MDQ-30). Dysphagia symptoms were determined based on the MDQ-30 question: 'How would you rate the severity of your trouble swallowing in the past 30 days' with a 5 point scale ranging from 'does not bother me at all' to 'very severe, markedly affects my lifestyle'. Patients must have marked a score of 3 or higher corresponding to 'Moderate, cannot be ignored, but does not affect my lifestyle' to be included in the study.

Countries

United States