ASTERIX: Low Dose ASA and Nexium - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00251966

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 III

MedlinePlus related topics: Endoscopy GERD

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
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.

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

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

Study ID Numbers:	D9617C00011
Study First Received:	November 9, 2005
Last Updated:	November 9, 2005
ClinicalTrials.gov Identifier:	NCT00251966
Health Authority:	Canada: Health Canada

Keywords provided by AstraZeneca:

Prevention of gastroduodenal lesions
erosive oesophagitis
upper GI symptoms

Study placed in the following topic categories:

Deglutition Disorders
Esophageal Motility Disorders
Esophagitis
Digestive System Diseases
Aspirin

Esophageal disorder
Gastrointestinal Diseases
Omeprazole
Esophageal Diseases
Gastroesophageal Reflux

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Anti-Ulcer Agents

Gastrointestinal Agents
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009