Open, Randomized, Two Way Crossover Study Comparing the Effect of Esomeprazole Adminstered Orally and iv

AstraZeneca60 enrolled

Overview

The purpose of this study is to examine the effects of Nexium at a dose of 20mg administered orally compared to intravenously on the maximum acid output in subjects with symptoms of Gastroesophageal reflux disease (GERD).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Gastroesophageal Reflux Disease

Interventions

EsomeprazoleDRUG

Oral and Intravenous

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Heartburn on 2 out of the last 7 days prior to screening or a diagnosis of GERD (with or without a diagnosis of Erosive eosphagitis) or a documented diagnosis of GERD within 6 months prior to screening, with or without a history of EE. * Body Mass Index within the limits specified in the protocol. Exclusion Criteria: * History of esophageal, duodenal or gastric surgery * History of severe liver disease. * Any other significant disease or pathology judged to be clinically significant by the investigator.

Outcomes

Primary Outcomes

To compare the maximum acid output during pentagastrin stimulation after 10 days of Nexium dosing administered orally with 10 days dosing via intravenous administration.

Time frame: Every 10 days

Secondary Outcomes

To compare basal acid output at steady state and when switching between Oral and IV administration of Nexium.

Time frame: Post Day 10

To compare maximum acid output when switching between Oral and IV adminstration of Nexium

Time frame: Post Day 10

Safety assessment via adverse event recording.

Time frame: At each visit

Data from ClinicalTrials.gov

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