An Open, Randomized, Two Way Crossover Study Comparing the Effect of 20mg 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)

Official Title: “An Open, Randomized, Two Way Crossover Study Comparing the Effect of 20mg 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)

Intervention(s) in this Clinical Trial

• Drug: Esomeprazole
  • 20mg oral
• Drug: Esomeprazole
  • 15 minute intravenous infusion

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • 20mg oral
• Active Comparator: 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 Investigator: AstraZeneca Industry

Information obtained from ClinicalTrials.gov on February 08, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00629564

Study ID Number: SH-NEP-0012

ClinicalTrials.gov Identifier: NCT00629564

Health Authority: United States: Food and Drug Administration