Ulcer Prevention II

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: NSAID Associated Gastric Ulcers

Treatments: Drug: Esomeprazole; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00629928

SH-NEN-0014

D9617C00014

Details and patient eligibility

About

Nonsteroidal anti-inflammatory drugs (NSAIDS) are often associated with gastric ulcers. This study looks at the prevention of these gastric ulcers, in patients deemed to be at risk, with either esomeprazole 40 mg once daily; esomeprazole 20 mg once daily.

Enrollment: 800 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. No active/current gastric or duodenal ulcer on baseline endoscopy.
2. A clinical diagnosis of a chronic condition that requires daily NSAID treatment for at least 6 months.
3. Other inclusion criteria, as defined in the protocol.

Exclusion criteria

1. History of esophageal, gastric or duodenal surgery, except the simple closure of an ulcer.

• 2. History of severe liver disease, including (but not limited to) cirrhosis and acute or chronic hepatitis.
• 3. Other criteria, as defined in the protocol.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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800 participants in 3 patient groups, including a placebo group

1

Experimental group

Description:

20mg capsule once daily

Treatment:

Drug: Esomeprazole

Drug: Esomeprazole

2

Experimental group

Description:

40mg capsule daily

Treatment:

Drug: Esomeprazole

Drug: Esomeprazole

3

Placebo Comparator group

Treatment:

Drug: Placebo