Official Title: “An Open, Randomised Two Way Crossover Study Comparing the Effects of 20mg of Esomeprazole Administered Orally and Intravenously as a 3 Minute Injection on Basal and Pentagastrin-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 20mg administered orally compared to intravenously on the maximum acid output in subjects with symptoms of Gastroesophageal reflux disease (GERD).

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Crossover Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Esomeprazole
  • Oral and Intravenous

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • 20mg oral
• Experimental: 2
  • 20mg IV

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
    

Secondary Measures

• To compare basal acid output at steady state and when switching between Oral and IV administration of Nexium.
  • Time Frame: Post Day 10
    
• To compare maximum acid output when switching between Oral and IV adminstration of Nexium
  • Time Frame: Post Day 10
    
• Safety assessment via adverse event recording.
  • Time Frame: At each visit
    

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) or a documented diagnosis of GERD within 6 months prior to screening, with or without a history of EE.
• 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

Lead Sponsor: AstraZeneca

Overall Clinical Trial Officials and Contacts

Paula Fernstrom Study Director Nexium Global Product Director, AstraZeneca  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00626262

Study ID Number: D9615C00014

ClinicalTrials.gov Identifier: NCT00626262

Health Authority: United States: Food and Drug Administration