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

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Gastroesophageal Reflux Disease

Intervention: Esomeprazole (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Paula Fernstrom, Study Director, Affiliation: Nexium Global Product Director, AstraZeneca

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).

Clinical Details

Official title: 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)

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

Primary outcome: To compare the maximum acid output during pentagastrin stimulation after 10 days of Nexium dosing administered orally with 10 days dosing via intravenous administration.

Secondary outcome:

To compare basal acid output at steady state and when switching between Oral and IV administration of Nexium.

To compare maximum acid output when switching between Oral and IV adminstration of Nexium

Safety assessment via adverse event recording.

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Additional Information

Starting date: July 2002
Last updated: January 21, 2011

Page last updated: August 23, 2015

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