Official Title: “An Open, Randomized, Two-Way Crossover Study Comparing the Effect of 40mg Esomeprazole Administered Orally and Intravenously as a 15 Minute Infusion on Basal and Pentagastrin-Stimulated Acid Output in Subjects With Symptoms of Gastroesophageal Reflux Disease (GERD).”

This study looks at the effect on basal and pentagastrin-stimulated acid output of 40 mg Esomeprazole (Nexium) administered orally and intravenously as a 15-minute infusion to people with symptoms of Gastroesophageal Reflux Disease (GERD)

Study Type: Interventional

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

Study Primary Completion Date: October 2002

Intervention(s) in this Clinical Trial

• Drug: Esomeprazole
  • 40mg oral
• Drug: Esomeprazole
  • 15 minute intravenous infusion

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • 40mg administered orally
• Experimental: 2
  • 15 minute intravenous infusion

Primary Measures

• The maximal acid output (MAO) during pentagastrin stimulation after 10 days administration of 40 mg esomeprazole for both study periods.
  • Time Frame: MAO will be assessed after 10 days of treatment (Day 11 or Day 20)
    

Secondary Measures

• Basal acid output (BAO) after 10 days administration of 40 mg esomeprazole for both study periods. (Day 11 or Day 20)
  • Time Frame: BAO will be assessed after 10 days of treatment
    
• To compare MAO when switching (after Day 2 in the second study period versus after Day 10 in the first study period) from oral to intravenous dosing and from intravenous to oral dosing.
  • Time Frame: Assessments at Day 2 and after Day 10 (Day 11 or Day 20)
    
• To evaluate the safety of intravenous esomeprazole in subjects with symptoms of GERD.
  • Time Frame: Safety assessments throughout the study
    

Inclusion Criteria:

• 1. Heartburn on at least 2 days of the past 7 days prior to screening, with or without a history of EE or a documented diagnosis of GERD within 6 months prior to screening, with or without a history of EE.
• 2. Body mass index (BMI) of ≥18.5 and ≤35 kg/m2. [BMI will be calculated using the following formula: weight (kg)/height (m)2.]
• 3. Able to communicate with the investigator and to understand and comply with the requirements of the study.

Exclusion Criteria:

• 1. History of esophageal, gastric, or duodenal surgery, except for simple closure of an ulcer.
• 2. History of severe liver disease, including (but not limited to) cirrhosis and acute or chronic hepatitis.
• 3. Any significant "alarm symptoms", within the past 6 months, such as, unintentional weight loss, gastrointestinal bleeding, jaundice or any other sign indicating serious or malignant disease.
• 4. Abnormal lab test results, as indicated in the protocol.
• 5. Other diseases, as indicated in the protocol.

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 August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00635414

Study ID Number: SH-NEP-0011

ClinicalTrials.gov Identifier: NCT00635414

Health Authority: United States: Food and Drug Administration