Ulcer Prevention II - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00629928

Purpose

Nonsteroidal anti-inflammatory drugs (NSAIDS) are often associated with gastric ulcers. This study looks at the prevention of these gastric ulcers, in patients deemed to be at risk, with either esomeprazole 40 mg once daily; esomeprazole 20 mg once daily.

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

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Comparative Efficacy and Safety of Nexium Delayed-Release Capsules (40mg qd and 20mg qd) Versus Placebo for the Prevention of Gastric and Duodenal 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 treatment for the prevention of gastric (and duodenal) ulcers in patients receiving daily NSAID therapy. [ Time Frame: Assessments at Week 0, Week 4, Week 12, Week 26 ] [ Designated as safety issue: No ]

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 20 mg 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 20 mg qd versus placebo when administered for up to 6 months to patients receiving daily NSAID therapy. [ Time Frame: Assessments at Week 0, Week 4, Week 12, Week 26 ]

Estimated Enrollment:	800
Study Start Date:	February 2001
Study Completion Date:	April 2003
Primary Completion Date:	February 2003 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 20mg capsule once daily	Drug: Esomeprazole 20mg oral capsule daily
2: Experimental 40mg capsule daily	Drug: Esomeprazole 40mg oral capsule daily
3: Placebo Comparator	Drug: Placebo

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

No active/current 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:

1. History of esophageal, gastric or duodenal surgery, except the simple closure of an ulcer.

2. History of severe liver disease, including (but not limited to) cirrhosis and acute or chronic hepatitis.
3. Other criteria, as defined in the protocol.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00629928

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Paula Fernstrom

Nexium Global Product Director, AstraZeneca

More Information

No publications provided

Study ID Numbers:	SH-NEN-0014, D9617C00014
Study First Received:	February 27, 2008
Last Updated:	June 9, 2009
ClinicalTrials.gov Identifier:	NCT00629928 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

NSAID, Nexium, esomeprazole, Gastric Ulcers

Additional relevant MeSH terms:

Stomach Ulcer
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Ulcer
Gastrointestinal Agents
Omeprazole
Enzyme Inhibitors

Pharmacologic Actions
Digestive System Diseases
Stomach Diseases
Pathologic Processes
Therapeutic Uses
Anti-Ulcer Agents
Peptic Ulcer

ClinicalTrials.gov processed this record on February 08, 2010