ASTERIX: Low Dose ASA and Nexium - Full Text View

Sponsor:	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 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

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

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 May 24, 2012