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

CompletadoFase 3ClinicalTrials.gov

ID: NCT00441727Tipo: INTERVENTIONALInicio: 1 de feb de 2007Fin estimado: 1 de ago de 2008

Traducción no disponible, mostrando original

Resumen

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

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Daily intake of low-dose Aspirin (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 and with stable coronary artery disease.
Aged ≥60 years and with complaints of upper gastrointestinal (GI) symptoms that, as judged by the investigator, requires an Esophagogastroduodenoscopy (EGD) and with the finding of ≥5 gastric and/or duodenal erosions at the baseline endoscopy.

Criterios de exclusión

Peptic ulcer(s) at baseline esophagogastroduodenoscopy (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.

Intervenciones

drug

Esomeprazole 40 mg

Esomeprazole 40 mg once daily

drug

Esomeprazole 20 mg

Esomeprazole 20 mg once daily

drug

Placebo

Placebo once daily

Ubicaciones

Research Site

Capital Federal, Buenos Aires, Argentina

Research Site

Loma Hermosa, Buenos Aires, Argentina

Research Site

Lomas de Zamora, Buenos Aires, Argentina

Research Site

Buenos Aires, Buenos Aires- Argentina, Argentina

Research Site

Rosario, Santa Fe Province, Argentina

Research Site

Mendoza, Argentina

Research Site

Rosario, Argentina

Patrocinadores

PrincipalAstraZeneca

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