Study Comparing the Effects of Esomeprazole Adminstered Orally and Intravenously on Basal and Pentrigastrin-stimulated Acid Output in Subjects With Symptoms of Gastroesophageal Reflux Disease (GERD)

AstraZeneca

Status and phase: Completed; Phase 4

Conditions: Gastroesophageal Reflux Disease

Treatments: Drug: Esomeprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT00625495

D9615C00013

Details and patient eligibility

About

The purpose of this study is to examine the effects of Nexium at a dose of 40mg administered orally compared to intravenously on the maximum acid output in subjects with symptoms of Gastroesophageal reflux disease (GERD).

Enrollment: 60 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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).
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

1

Experimental group

Description:

IV Nexium

Treatment:

Drug: Esomeprazole

Drug: Esomeprazole

2

Experimental group

Description:

Oral Nexium

Treatment:

Drug: Esomeprazole

Drug: Esomeprazole