Efficacy and safety study of Esomeprazole 20mg qd vs Ranitidine 150mg bid in patients with an NSAID-induced gastric ulcer

Study identifier:D9617L00001

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A multicenter, randomized, double-blind, double-dummy, parallel-group, 8 week comparative efficacy and safety study of esomeprazole 20 mg every day (qd) versus Ranitidine 150 mg twice a day (bid) in patients with an NSAID-associated gastric ulcer when daily NSAID is continued

Medical condition

Gastric Ulcer

Phase

Phase 3

Healthy volunteers

No

Study drug

Esomeprazole, Ranitidine

Sex

All

Actual Enrollment

397

Study type

Interventional

Age

18 Years - 70 Years

Date

Study Start Date: 01 Mar 2006
Primary Completion Date: -
Study Completion Date: 01 Nov 2008

Study design

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

Verification:

Verified 01 Jun 2010 by AstraZeneca Pharmaceuticals

Sponsors

AstraZeneca Pharmaceuticals

Collaborators

-

Inclusion and exclusion criteria