Prevention of Gastric Ulcers - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00629512

Purpose

Nonsteroidal anti-inflammatory drugs (NSAIDS) are often associated with gastric ulcers. This study looks at the prevention of these gastric ulcers with one of the three following treatment groups for up to 8 weeks: esomeprazole 40 mg once daily; esomeprazole 20 mg once daily; versus placebo; in patients at risk.

Condition	Intervention	Phase
NSAID Associated Gastric Ulcers	Drug: Esomeprazole Drug: Placebo	Phase III

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

Resource links provided by NLM:

Drug Information available for: Omeprazole Omeprazole magnesium Esomeprazole Sodium Esomeprazole magnesium

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

To assess the efficacy of esomeprazole 40 mg qd versus placebo and esomeprazole 20 mg qd versus placebo for up to 6 months of the treatment for the prevention of gastric (and/or duodenal) ulcers in patients receiving daily NSAID therapy and being at risk [ Time Frame: Assessments at Week 0, Week 4, Week 12, Week 26 ]

Secondary Outcome Measures:

Investigator-assessed symptoms, defined as control of NSAID-associated GI symptoms for up to 6 months of treatment with esomeprazole 40 mg qd versus placebo and esomeprazole 20mg qd versus placebo in patients receiving daily NSAID therapy. [ Time Frame: Assessments at Week 0, Week 4, Week 12, Week 26 ]
Safety and tolerability of esomeprazole 40 mg qd versus placebo and esomeprazole 20mg qd versus placebo for up to 6 months of treatment in patients receiving daily NSAID therapy [ Time Frame: Assessments at Week 0, Week 4, Week 12, Week 26 ]

Estimated Enrollment:	504
Study Start Date:	March 2001
Study Completion Date:	December 2002
Primary Completion Date:	December 2002 (Final data collection date for primary outcome measure)

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	Drug: Placebo

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

No gastric or duodenal ulcer on baseline endoscopy.
A clinical diagnosis of a chronic condition that requires daily NSAID treatment for at least 6 months.
Other inclusion criteria, as defined in the protocol.

Exclusion Criteria:

History of esophageal, gastric or duodenal surgery, except the simple closure of an ulcer.
History of severe liver disease, including (but not limited to) cirrhosis and acute or chronic hepatitis.
Other criteria, as defined in the protocol.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00629512

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:	Professor Chris Hawkey	Queens Medical Centre
Study Director:	Paula Fernstrom	Nexium Global Product Director, AstraZeneca

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00629512 History of Changes
Other Study ID Numbers:	SH-NEN-0013
Study First Received:	February 27, 2008
Last Updated:	March 12, 2009
Health Authority:	United States: Food and Drug Administration; Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Bulgaria: Ministry of Health; Brazil: National Health Surveillance Agency; Canada: Health Canada; Hong Kong: Department of Health; Hungary: National Institute of Pharmacy; Mexico: Ministry of Health; Norway: Directorate for Health and Social Affairs; Poland: Ministry of Science and Higher Education; Sweden: Medical Products Agency; Singapore: Clinical Trials & Epidemiology Research Unit (CTERU); United States of America: Food and Drug Administration; South Africa: Medicines Control Council

Keywords provided by AstraZeneca:

NSAID, Nexium, esomeprazole, Gastric Ulcers

Additional relevant MeSH terms:

Stomach Ulcer
Ulcer
Peptic Ulcer
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Pathologic Processes

Omeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 12, 2012