Comparative Efficacy & Safety Study of D961H Versus Placebo for the Prevention of Gastric and Duodenal Ulcers With Low-dose Aspirin

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Prevention

Treatments: Drug: Placebo; Drug: Esomeprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT01069939

D961PC00001

Details and patient eligibility

About

To assess the efficacy of D961H 20 mg once daily (q.d.) versus placebo in continuous treatment involving patients with a history of gastric and/or duodenal ulcers receiving daily Low-dose aspirin therapy by evaluating time from randomisation to occurrence of gastric and/or duodenal ulcers.

Enrollment: 427 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Provision of written informed consent before starting the study-related procedures and examinations
• Patients who have the history of gastric and/or duodenal ulcer.
• A diagnosis of a chronic condition (angina pectoris, myocardial infarction and ischemic cerebrovascular disorder, etc., requiring prevention of thrombosis or embolism) which requires taking the prescribed LDA during the study treatment period.

Exclusion criteria

• Having gastric or duodenal ulcer (except for ulcer scar).
• History of esophageal, gastric or duodenal surgery, except for simple closure of perforation.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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427 participants in 2 patient groups, including a placebo group

Esomeprazole 20mg

Experimental group

Description:

Esomeprazole 20mg once daily oral

Treatment:

Drug: Esomeprazole

Placebo

Placebo Comparator group

Description:

Placebo once daily oral

Treatment:

Drug: Placebo