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)
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Gastroesophageal Reflux Disease (GERD)
Intervention: Esomeprazole (Drug); Esomeprazole (Drug)
Phase: Phase 3
Sponsored by: AstraZeneca
Official(s) and/or principal investigator(s):
Paula Fernstrom, Study Director, Affiliation: Nexium Global Product Director, AstraZeneca
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).
Official title: An Open, Randomised Two Way Crossover Study Comparing the Effects of 40mg of Esomeprazole Adminstered Orally and Intravenously as a 3 Minute Injection on Basal and Pentrigastrin-Stimulated Acid Output in Subjects With Symptoms of Gastroesophageal Reflux Disease (GERD)
Study design: Treatment, Randomized, Open Label, Crossover Assignment, Safety/Efficacy Study
Primary outcome: To compare the maximum acid output during pentagastrin stimulation after 10 days of Nexium dosing administered orally with 10 days dosing via intravenous administration.
To compare basal acid output at steady state and when switching between Oral and IV adminstration of Nexium.
To compare maximum acid output when switching between Oral and IV adminstration of Nexium
Safety assessment via adverse event recording
Minimum age: 18 Years.
Maximum age: 75 Years.
- 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
- 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
Locations and Contacts
Starting date: September 2002
Ending date: January 2003
Last updated: February 20, 2008