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) (Oberon)

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Gastric Ulcer; Duodenal Ulcer

Treatments: Drug: Placebo; Drug: Esomeprazole 20 mg; Drug: Esomeprazole 40 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00441727

EudraCT No. 2006-005073-22

D961FC00003

Details and patient eligibility

About

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.

Enrollment: 2,426 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

2,426 participants in 3 patient groups, including a placebo group

Esomeprazole 40 mg

Experimental group

Description:

Esomeprazole 40 mg

Treatment:

Drug: Esomeprazole 40 mg

Esomeprazole 20 mg

Experimental group

Description:

Esomeprazole 20 mg

Treatment:

Drug: Esomeprazole 20 mg

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo