Ulcer Prevention II

AstraZeneca800 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

800

Conditions

NSAID Associated Gastric Ulcers

Interventions

EsomeprazoleDRUG

20mg oral capsule daily

EsomeprazoleDRUG

40mg oral capsule daily

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

To assess the efficacy of esomeprazole 40 mg qd versus placebo and esomeprazole 20 mg qd versus placebo for up to 6 months of treatment for the prevention of gastric (and duodenal) ulcers in patients receiving daily NSAID therapy.

Time frame: Assessments at Week 0, Week 4, Week 12, Week 26

Secondary Outcomes

Investigator assessed symptoms, defined as control of NSAID-associated GI symptoms for up to 6 months of treatment with esomeprazole 40 mg qd versus placebo and esomeprazole 20 mg qd versus placebo in patients receiving daily NSAID therapy.

Time frame: Assessments at Week 0, Week 4, Week 12, Week 26

Safety and tolerability of esomeprazole 40 mg qd versus placebo and esomeprazole 20 mg qd versus placebo when administered for up to 6 months to patients receiving daily NSAID therapy.

Time frame: Assessments at Week 0, Week 4, Week 12, Week 26

Data from ClinicalTrials.gov

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