A Comparative Efficacy and Safety Study of Nexium Delayed-Release Capsules (40mg qd and 20mg qd) versus Ranitidine 150mg bid for the Healing of NSAID-Associated Gastric Ulcers when daily NSAID use is continued

Study identifier:SH-NEN-0006

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 Delayed-Release Capsules (40mg qd and 20mg qd) versus Ranitidine 150mg bid for the Healing of NSAID-Associated Gastric Ulcers when daily NSAID use is continued

Medical condition

NSAID associated Gastric Ulcers

Phase

Phase 3

Healthy volunteers

Study drug

Esomeprazole, Ranitidine

Sex

Unmapped

Actual Enrollment

400

Study type

Interventional

Age

18 Years +

Date

Study Start Date: 01 Feb 2001

Primary Completion Date: 01 Oct 2003

Study Completion Date: 01 Oct 2003

Study design

Allocation: None
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals

Collaborators

Inclusion and exclusion criteria

No locations available

Arms	Assigned Interventions
Experimental: 1 20mg Oral tablet daily	Drug: Esomeprazole 20mg Oral tablet once daily Other Name: Nexium
Experimental: 2 40mg oral tablet daily	Drug: Esomeprazole 40mg oral tablet once daily Other Name: Nexium
Active Comparator: 3 150mg oral twice daily	Drug: Ranitidine 150mg oral twice daily Other Name: Zantac

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=1126&filename=CSR-SH-NEN-0006.pdf
Download
CSR-SH-NEN-0006.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

A Comparative Efficacy and Safety Study of Nexium Delayed-Release Capsules (40mg qd and 20mg qd) versus Ranitidine 150mg bid for the Healing of NSAID-Associated Gastric Ulcers when daily NSAID use is continued

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=1126&filename=CSR-SH-NEN-0006.pdf

CSR-SH-NEN-0006.pdf

Trial Results Summaries

Contacts

Contact

Contact Backup

Investigators

Principal Investigator