Gastroesophageal Reflux Disease Clinical Trial
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)
Verified date | January 2011 |
Source | AstraZeneca |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 60 |
Est. completion date | November 2002 |
Est. primary completion date | November 2002 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | To compare basal acid output at steady state and when switching between Oral and IV adminstration of Nexium. | Post Day 10 | ||
Secondary | To compare maximum acid output when switching between Oral and IV adminstration of Nexium | Post Day 10 | ||
Secondary | Safety assessment via adverse event recording | At each visit |
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