Prevention of Gastric Ulcers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

504 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-03-31

Study Completion Date

2002-12-31

Brief Summary

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Nonsteroidal anti-inflammatory drugs (NSAIDS) are often associated with gastric ulcers. This study looks at the prevention of these gastric ulcers with one of the three following treatment groups for up to 8 weeks: esomeprazole 40 mg once daily; esomeprazole 20 mg once daily; versus placebo; in patients at risk.

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Detailed Description

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Conditions

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NSAID Associated Gastric Ulcers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Study Groups

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1

20mg oral daily

Group Type EXPERIMENTAL

Esomeprazole

Intervention Type DRUG

20mg oral daily

2

40mg oral daily

Group Type EXPERIMENTAL

Esomeprazole

Intervention Type DRUG

40mg oral daily

3

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Esomeprazole

20mg oral daily

Intervention Type DRUG

Esomeprazole

40mg oral daily

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Nexium Nexium

Eligibility Criteria

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Inclusion Criteria

1. No 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.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No