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

Phase 4

Completed

• Conditions: GERD
• Interventions: Drug: Esomeprazole

• Registration Number: NCT00635414
• Lead Sponsor: AstraZeneca

Brief Summary

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2002-08
• Primary Completion: 2002-10
• Study Completion: 2002-10
• Study First Submitted: 2008-03-06
• Study First Submitted QC: 2008-03-06
• Study First Posted: 2008-03-13
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-24
• Last Update Posted: 2011-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2	Esomeprazole	15 minute intravenous infusion
1	Esomeprazole	40mg administered orally

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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