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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00625495
Other study ID # D9615C00013
Secondary ID
Status Completed
Phase Phase 4
First received February 20, 2008
Last updated January 21, 2011
Start date September 2002
Est. completion date November 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

The purpose of this study is to examine the effects of Nexium at a dose of 40mg administered orally compared to intravenously on the maximum acid output in subjects with symptoms of Gastroesophageal reflux disease (GERD).


Recruitment information / eligibility

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

- 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

Study Design

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


Intervention

Drug:
Esomeprazole
40mg Intravenous infusion over 3 minutes
Esomeprazole
40mg Oral

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
AstraZeneca

Outcome

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