Open, Randomized, Two Way Crossover 40mg, orally and intravenously
Study identifier:SH-NEP-0011
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
An Open, Randomized, Two-way Crossover Study Comparing the Effect of 40mg 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).
Medical condition
GERD
Phase
Phase 4
Healthy volunteers
No
Study drug
Esomeprazole
Sex
All
Actual Enrollment
60
Study type
Interventional
Age
18 Years - 75 Years
Date
Study Start Date: 01 Aug 2002
Primary Completion Date: 01 Oct 2002
Study Completion Date: 01 Oct 2002
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 40mg administered orally | Drug: Esomeprazole 40mg oral Other Name: Nexium |
| Experimental: 2 15 minute intravenous infusion | Drug: Esomeprazole 15 minute intravenous infusion Other Name: Nexium |
Contacts
Investigators
Principal Investigator
Paula Fernstrom
Nexium Global Product Director, AstraZeneca
