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)
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)...
Brief Summary
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)”
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 Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
- Study Primary Completion Date: November 2002
Intervention(s) in this Clinical Trial
- Drug: Esomeprazole
- 40mg Intravenous infusion over 3 minutes
- Drug: Esomeprazole
- 40mg Oral
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: 1
- IV Nexium
- Experimental: 2
- Oral Nexium
Outcome Measures for this Clinical Trial
Primary Measures
- 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
- Time Frame: Every 10 days
Secondary Measures
- To compare basal acid output at steady state and when switching between Oral and IV adminstration of Nexium.
- Time Frame: Post Day 10
- Time Frame: Post Day 10
- To compare maximum acid output when switching between Oral and IV adminstration of Nexium
- Time Frame: Post Day 10
- Time Frame: Post Day 10
- Safety assessment via adverse event recording
- Time Frame: At each visit
- Time Frame: At each visit
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 75 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: AstraZeneca Industry
Overall Clinical Trial Officials and Contacts
Paula Fernstrom Study Director Nexium Global Product Director, AstraZeneca
Additional Information
Information obtained from ClinicalTrials.gov on February 08, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00625495
Study ID Number: D9615C00013
ClinicalTrials.gov Identifier: NCT00625495
Health Authority: United States: Food and Drug Administration
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00625495
