Status:
COMPLETED
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)
Lead Sponsor:
AstraZeneca
Conditions:
Gastric Ulcer
Duodenal Ulcer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 acetylsal...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
2426 Patients enrolled
Trial Details
Trial ID
NCT00441727
Start Date
February 1 2007
End Date
August 1 2008
Last Update
July 16 2012
Active Locations (189)
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1
Research Site
Birmingham, Alabama, United States
2
Research Site
Tucson, Arizona, United States
3
Research Site
Anaheim, California, United States
4
Research Site
Lancaster, California, United States