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)

Condition(s) targeted: GERD

Intervention: Esomeprazole (Drug); Esomeprazole (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: AstraZeneca

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: 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)

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

Primary outcome: The maximal acid output (MAO) during pentagastrin stimulation after 10 days administration of 40 mg esomeprazole for both study periods.

Secondary outcome:

Basal acid output (BAO) after 10 days administration of 40 mg esomeprazole for both study periods. (Day 11 or Day 20)

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.

To evaluate the safety of intravenous esomeprazole in subjects with symptoms of GERD.

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

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.

Starting date: September 2002
Ending date: December 2002
Last updated: February 27, 2008