Open, Randomized, Two Way Crossover Study Comparing the Effect of Esomeprazole Adminstered Orally and iv

An Open, Randomised Two Way Crossover Study Comparing the Effects of 20mg of Esomeprazole Administered Orally and Intravenously as a 3 Minute Injection 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

NCT00626262

Enrollment

Registered

2008-02-29

Start date

2002-07-31

Completion date

2002-10-31

Last updated

2011-01-24

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

Conditions

Gastroesophageal Reflux Disease

Keywords

Gastroesophageal reflux disease, Nexium, Esomeprazole, Administration methods.

Brief summary

The purpose of this study is to examine the effects of Nexium at a dose of 20mg administered orally compared to intravenously on the maximum acid output in subjects with symptoms of Gastroesophageal reflux disease (GERD).

Interventions

DRUGEsomeprazole

Oral and Intravenous

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Heartburn on 2 out of the last 7 days prior to screening or a diagnosis of GERD (with or without a diagnosis of Erosive eosphagitis) or a documented diagnosis of GERD within 6 months prior to screening, with or without a history of EE. * Body Mass Index within the limits specified in the protocol.

Exclusion criteria

* History of esophageal, duodenal or gastric surgery * History of severe liver disease. * Any other significant disease or pathology judged to be clinically significant by the investigator.

Design outcomes

Primary

Measure	Time frame
To compare the maximum acid output during pentagastrin stimulation after 10 days of Nexium dosing administered orally with 10 days dosing via intravenous administration.	Every 10 days

Secondary

Measure	Time frame
To compare basal acid output at steady state and when switching between Oral and IV administration of Nexium.	Post Day 10
To compare maximum acid output when switching between Oral and IV adminstration of Nexium	Post Day 10
Safety assessment via adverse event recording.	At each visit

Outcome results

None listed

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