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)
- Registration Number
- NCT00625495
- Lead Sponsor
- AstraZeneca
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 1 Esomeprazole IV Nexium 2 Esomeprazole Oral Nexium
- Primary Outcome Measures
Name Time Method To compare the maximum acid output during pentagastrin stimulation after 10 days of Nexium dosing administered orally with 10 days dosing via intravenous administration. Every 10 days
- Secondary Outcome Measures
Name Time Method To compare basal acid output at steady state and when switching between Oral and IV adminstration of Nexium. Post Day 10 To compare maximum acid output when switching between Oral and IV adminstration of Nexium Post Day 10 Safety assessment via adverse event recording At each visit