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ASTERIX: Low Dose ASA and Nexium

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00251966
First received: November 9, 2005
Last updated: March 11, 2009
Last verified: March 2009
History of Changes
  Purpose

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 Intervention Phase
Gastroesophageal Reflux
 Drug: Esomeprazole
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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.

Resource links provided by NLM:

MedlinePlus related topics: Endoscopy GERD
U.S. FDA Resources

Further study details as provided by AstraZeneca:

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

Estimated Enrollment: 960
Study Start Date: May 2004
Study Completion Date: September 2005
  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00251966     History of Changes
Other Study ID Numbers: D9617C00011
Study First Received: November 9, 2005
Last Updated: March 11, 2009
Health Authority: Canada: Health Canada

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

ClinicalTrials.gov processed this record on June 17, 2013