Study of Esomeprazole 20 mg or 40 mg vs Placebo Effectiveness on the Occurrence of Peptic Ulcers in Subjects on Low Dose Acetylsalicylic Acid (LDA)

Completed · Phase 3 · Has a placebo group

Conditions studied: Gastric Ulcer, Duodenal Ulcer

In brief

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.

Key facts

Study ID

NCT00441727

Run by

AstraZeneca

People needed

2426

Starts

2007-02-01

Expected to finish

2008-08-01

Last updated by the study team

2012-07-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Research Site — Tucson, Arizona, United States
• Research Site — Anaheim, California, United States
• Research Site — Lancaster, California, United States
• Research Site — Los Angeles, California, United States
• Research Site — Orange, California, United States
• Research Site — San Carlos, California, United States
• Research Site — San Diego, California, United States
• Research Site — Torrington, Connecticut, United States
• Research Site — Boynton Beach, Florida, United States
• Research Site — Hollywood, Florida, United States
• Research Site — Jacksonville, Florida, United States
• Research Site — Jupiter, Florida, United States
• Research Site — Miami, Florida, United States
• Research Site — New Smyrna Beach, Florida, United States
• Research Site — Pembroke Pines, Florida, United States
• Research Site — Plantation, Florida, United States
• Research Site — South Miami, Florida, United States
• Research Site — Tampa, Florida, United States
• Research Site — Zephyrhills, Florida, United States
• Research Site — Fulton, Illinois, United States
• Research Site — Wichita, Kansas, United States
• Research Site — Shreveport, Louisiana, United States
• Research Site — Baltimore, Maryland, United States
• Research Site — Hollywood, Maryland, United States
• Research Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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