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

Study drug

Esomeprazole

Sex

All

Actual Enrollment

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

Collaborators

Inclusion and exclusion criteria

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

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=1129&filename=CSR-SH-NEP-0011.pdf
Download
CSR-SH-NEP-0011.pdf
Download
Trial Results Summaries
Available here

Contacts

Contact

null AstraZeneca Clinical Study Information

800-236-9933

information.center@astrazeneca.com

Contact Backup

null AstraZeneca Information, (Outside US)

001-800-236-9933

Investigators

Principal Investigator

Paula Fernstrom

Nexium Global Product Director, AstraZeneca