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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)

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)

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00629564
Enrollment
60
Registered
2008-03-06
Start date
2002-09-30
Completion date
2002-10-31
Last updated
2011-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

GERD

Keywords

Gastroesophageal Reflux Disease (GERD), esomeprazole, Nexium

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)

Interventions

DRUGEsomeprazole

20mg oral

Sponsors

AstraZeneca
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime 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

MeasureTime 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026