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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00629564
Other study ID # SH-NEP-0012
Secondary ID D9615C00012
Status Completed
Phase Phase 4
First received February 27, 2008
Last updated January 24, 2011
Start date September 2002
Est. completion date October 2002

Study information

Verified date January 2011
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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)


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date October 2002
Est. primary completion date October 2002
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Esomeprazole
20mg oral
Esomeprazole
15 minute intravenous infusion

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
AstraZeneca

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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)
Secondary To evaluate the safety of intravenous esomeprazole in subjects with symptoms of GERD. Safety assessments throughout the study
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