Study of Esomeprazole 20 mg or 40 mg vs Placebo Effectiveness on the Occurrence of Peptic Ulcers in Subjects on LDA - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00441727

Purpose

The purpose of this study is to compare the effect of esomeprazole 20 and 40 mg once daily versus placebo on the occurrence of peptic ulcers during 26 weeks in subjects on continuous low-dose acetylsalicylic acid.

Condition	Intervention	Phase
Gastric Ulcer Duodenal Ulcer	Drug: Esomeprazole	Phase III

MedlinePlus related topics: Peptic Ulcer

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, Parallel-Group, Multicentre, Phase III Study to Assess the Effect of Esomeprazole 20 and 40 mg od Versus Placebo on the Occurrence of Peptic Ulcers During 26 Weeks in Subjects on Continuous Low Dose Acetylsalicylic Acid (ASA)

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

The primary variable is time to occurrence of peptic ulcer(s).

Secondary Outcome Measures:

Time to occurrence of gastric/duodenal ulcer.
Dichotomized RDQ score for the dyspepsia/GERD dimension
Number of gastric/duodenal erosions
Adverse events, lab and vital signs

Enrollment:	2426
Study Start Date:	February 2007
Study Completion Date:	September 2008
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Daily intake of low-dose ASA
The subject must fulfill at least one of the following (a-e):
Aged ≥65 years.
Aged ≥18 years and with a documented history of uncomplicated peptic ulcer(s).
Aged ≥60 years and naïve to low-dose ASA (ie, treatment started within 1 month prior to randomization).
Aged ≥60 years with stable coronary artery disease.
Aged ≥60 years with complaints of upper GI symptoms that, as judged by the investigator, requires an EGD and with the finding of ≥5 gastric and/or duodenal erosions at the baseline endoscopy.

Exclusion Criteria:

Peptic ulcer(s) at baseline EGD.
Reflux esophagitis Los Angeles (LA) classification grade C or D at baseline
History of peptic ulcer complications such as clinically significant bleeding and/or perforation.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00441727

Show 193 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Tore Lind, MD, PhD	AstraZeneca
Principal Investigator:	James Scheiman, MD	University of Michigan

More Information

AstraZeneca Clinical Trial Information - Outside US This link exits the ClinicalTrials.gov site

Study ID Numbers:	D961FC00003, EudraCT No. 2006-005073-22
Study First Received:	February 27, 2007
Last Updated:	September 24, 2008
ClinicalTrials.gov Identifier:	NCT00441727
Health Authority:	United States: Food and Drug Administration; Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Australia: Department of Health and Ageing Therapeutic Goods Administration; Bulgaria: Bulgarian Drug Agency; Canada: Health Canada; Czech Republic: State Institute for Drug Control; Finland: National Agency for Medicines; Germany: Federal Institute for Drugs and Medical Devices; Hungary: National Institute of Pharmacy; Mexico: Federal Commission for Protection Against Health Risks; Norway: Norwegian Medicines Agency; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Portugal: National Pharmacy and Medicines Institute; Romania: National Medicines Agency; Russia: Pharmacological Committee, Ministry of Health; Slovakia: State Institute for Drug Control; South Africa: Medicines Control Council; Philippines: Bureau of Food and Drugs; South Korea: Korea Food and Drug Administration (KFDA); Thailand: Food and Drug Administration

Keywords provided by AstraZeneca:

Peptic ulcer
low-dose ASA

Study placed in the following topic categories:

Stomach Ulcer
Stomach Diseases
Digestive System Diseases
Aspirin
Gastrointestinal Diseases
Ulcer

Omeprazole
Intestinal Diseases
Duodenal Diseases
Peptic Ulcer
Duodenal Ulcer

Additional relevant MeSH terms:

Pathologic Processes
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