Long Term Study to investigate the Efficacy & Safety of D961H (Esomeprazole) for the prevention of NSAIDs-induced ulcer

Study identifier:D961HC00005

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Long Term Study to Investigate the Efficacy and Safety Study of D961H (Esomeprazole) (20 mg once daily) for the Prevention of Gastric and/or Duodenal Ulcers Associated with Daily Nonsteroidal Anti-inflammatory Drug (NSAID) Use

Medical condition

Gastric Ulcer, Rheumatoid Arthritis, Osteoarthritis

Phase

Phase 3

Healthy volunteers

Study drug

Esomeprazole 20 mg

Sex

All

Actual Enrollment

395

Study type

Interventional

Age

20 Years +

Date

Study Start Date: 01 Oct 2007

Primary Completion Date: 01 Sept 2009

Study Completion Date: 01 Sept 2009

Study design

Allocation: Non-randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention

Verification:

Verified 01 Aug 2012 by AstraZeneca Pharmaceuticals

Collaborators

Inclusion and exclusion criteria

Location

Research Site

Oita, Japan

Location

Research Site

Tokyo, Japan

Location

Research Site

Saitama, Japan

Arms	Assigned Interventions
Experimental: Esomeprazole 20 mg Esomeprazole 20 mg once daily	Drug: Esomeprazole 20 mg Esomeprazole 20 mg once daily

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=446&filename=CSP-D961HC00005.pdf
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https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=446&filename=CSR-D961HC00005.pdf
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CSP-D961HC00005.pdf
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CSR-D961HC00005.pdf
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Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca KK Clinical Study

+87-6-6453-7442

Investigators

Principal Investigator

Naotsugu Oyama

AstraZeneca

Long Term Study to investigate the Efficacy & Safety of D961H (Esomeprazole) for the prevention of NSAIDs-induced ulcer

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

Research Site

Research Site

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=446&filename=CSP-D961HC00005.pdf

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=446&filename=CSR-D961HC00005.pdf

CSP-D961HC00005.pdf

CSR-D961HC00005.pdf

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator