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Prevention of Gastric Ulcers

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ClinicalTrials.gov Identifier: NCT00629512
Recruitment Status : Completed
First Posted : March 6, 2008
Last Update Posted : March 13, 2009
Sponsor:
Information provided by:
AstraZeneca

Brief Summary:
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 or disease Intervention/treatment Phase
NSAID Associated Gastric Ulcers Drug: Esomeprazole Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 504 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : March 2001
Actual Primary Completion Date : December 2002
Actual Study Completion Date : December 2002

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 :
  1. 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 ]
  2. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. No gastric or duodenal ulcer on baseline endoscopy.
  2. A clinical diagnosis of a chronic condition that requires daily NSAID treatment for at least 6 months.
  3. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00629512


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

ClinicalTrials.gov Identifier: NCT00629512     History of Changes
Other Study ID Numbers: SH-NEN-0013
First Posted: March 6, 2008    Key Record Dates
Last Update Posted: March 13, 2009
Last Verified: March 2009

Keywords provided by AstraZeneca:
NSAID, Nexium, esomeprazole, Gastric Ulcers

Additional relevant MeSH terms:
Ulcer
Stomach Ulcer
Pathologic Processes
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Esomeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action