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ASTERIX: Low Dose ASA and Nexium

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ClinicalTrials.gov Identifier: NCT00251966
Recruitment Status : Completed
First Posted : November 11, 2005
Last Update Posted : March 12, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:
The purpose of the study is to evaluate the effect of esomeprazole 20 mg od versus placebo for the prevention of gastric and/or duodenal ulcers in patients taking low-dose ASA.

Condition or disease Intervention/treatment Phase
Gastroesophageal Reflux Drug: Esomeprazole Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 960 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: A Randomized Double-Blind Placebo-Controlled Study to Assess the Prevention of Low-Dose Acetylsalicylic Acid (ASA) Associated Gastroduodenal Lesions and Upper Gastrointestinal Symptoms in Patients Taking Esomeprazole 20 mg Once Daily for 26 Weeks.
Study Start Date : May 2004
Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. The primary variable is presence of gastric and/or duodenal ulcers at endoscopy over a 26-week period in patients taking low-dose ASA.

Secondary Outcome Measures :
  1. LA classification for the oesophagus at endoscopy. Upper GI symptoms assessed by the investigator at each study visit.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A clinical diagnosis of a condition (cardiovascular and/or cerebrovascular protection or other reasons) that requires daily intake of low-dose ASA, 75-325 mg, and is expected to continue for the duration of the study (daily is defined as at least 5 days per week).
  • Age >= 60 years.
  • No gastric and/or duodenal ulcer at the baseline endoscopy.
  • H. pylori negative by serology test at screening.

Exclusion Criteria:

  • Upper GI symptoms
  • Erosive oesophagitis
  • Malignancy
Contacts and Locations

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): NCT00251966


  Show 93 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca Nexium Medical Science Director, MD AstraZeneca
Principal Investigator: Neville Yeomans, MD Perth Medical School
More Information

ClinicalTrials.gov Identifier: NCT00251966     History of Changes
Other Study ID Numbers: D9617C00011
First Posted: November 11, 2005    Key Record Dates
Last Update Posted: March 12, 2009
Last Verified: March 2009

Keywords provided by AstraZeneca:
Prevention of gastroduodenal lesions
erosive oesophagitis
upper GI symptoms

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Esomeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action