NCT00625495CompletedPhase 4
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)
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 60
- Primary Endpoint
- To compare the maximum acid output during pentagastrin stimulation after 10 days of Nexium dosing administered orally with 10 days dosing via intravenous administration.
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
1
Experimental
IV Nexium
Intervention: Esomeprazole (Drug)
2
Experimental
Oral Nexium
Intervention: Esomeprazole (Drug)
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 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)
Investigators
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