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Ulcer Prevention II

NCT ID: NCT00629928

Last Updated: 2011-01-25

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

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-02-28

Study Completion Date

2003-03-31

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, in patients deemed to be at risk, with either esomeprazole 40 mg once daily; esomeprazole 20 mg once daily.

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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 capsule once daily

Group Type EXPERIMENTAL

Esomeprazole

Intervention Type DRUG

20mg oral capsule daily

2

40mg capsule daily

Group Type EXPERIMENTAL

Esomeprazole

Intervention Type DRUG

40mg oral capsule daily

3

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Esomeprazole

20mg oral capsule daily

Intervention Type DRUG

Esomeprazole

40mg oral capsule 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 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.

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

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Principal Investigators

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Paula Fernstrom

Role: STUDY_DIRECTOR

Nexium Global Product Director, AstraZeneca

Other Identifiers

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D9617C00014

Identifier Type: -

Identifier Source: secondary_id

SH-NEN-0014

Identifier Type: -

Identifier Source: org_study_id

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