Open, Randomized, Two Way Crossover 40mg, Orally and Intravenously

Study Overview
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Brief Summary
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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)

Official Title
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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).

Conditions
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GERD

Intervention / Treatment
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* Drug: Esomeprazole
* Drug: Esomeprazole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Body mass index (BMI) of ≥18.5 and ≤35 kg/m2. [BMI will be calculated using the following formula: weight (kg)/height (m)2.] Able to communicate with the investigator and to understand and comply with the requirements of the study. Exclusion Criteria: History of esophageal, gastric, or duodenal surgery, except for simple closure of an ulcer. History of severe liver disease, including (but not limited to) cirrhosis and acute or chronic hepatitis. 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. Abnormal lab test results, as indicated in the protocol. Other diseases, as indicated in the protocol.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>40mg administered orally | Drug: Esomeprazole<br>* 40mg oral<br>* Other names: Nexium;|
| Experimental: 2<br>15 minute intravenous infusion | Drug: Esomeprazole<br>* 15 minute intravenous infusion<br>* Other names: Nexium;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Basal acid output (BAO) after 10 days administration of 40 mg esomeprazole for both study periods. (Day 11 or Day 20) |  | 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. |  | 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. |  | Safety assessments throughout the study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastroesophageal Reflux Disease (GERD), esomeprazole, Nexium