Prevention of Gastric Ulcers

Study identifier:SH-NEN-0013

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Comparative Efficacy and Safety Study of Nexium (esomeprazole magnesium) Delayed-Release Capsules (40mg qd and 20mg qd) versus Placebo for the prevention of Gastric Ulcers Associated with Daily NSAID Use in Patients at Risk

Medical condition

NSAID associated Gastric Ulcers

Phase

Phase 3

Healthy volunteers

Study drug

Esomeprazole, Placebo

Sex

All

Actual Enrollment

504

Study type

Interventional

Age

18 Years +

Date

Study Start Date: 01 Mar 2001

Primary Completion Date: 01 Dec 2002

Study Completion Date: 01 Dec 2002

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Prevention

Verification:

Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals

Collaborators

Inclusion and exclusion criteria

No locations available

Arms	Assigned Interventions
Experimental: 1 20mg oral daily	Drug: Esomeprazole 20mg oral daily Other Name: Nexium
Experimental: 2 40mg oral daily	Drug: Esomeprazole 40mg oral daily Other Name: Nexium
Placebo Comparator: 3	-

"There is no result for the study"

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=1127&filename=CSR-SH-NEN-0013.pdf
Download
CSR-SH-NEN-0013.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

Professor Chris Hawkey

Queens Medical Centre