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A Comparative Efficacy and Safety Study of Nexium Delayed-Release Capsules (40mg qd and 20mg qd) Versus Ranitidine 150mg Bid for the Healing of NSAID-Associated Gastric Ulcers When Daily NSAID Use is Continued

NCT ID: NCT00633672

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

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-02-28

Study Completion Date

2003-10-31

Brief Summary

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Nonsteroidal anti-inflammatory drugs (NSAIDS) are often associated with gastric ulcers. This study looks at the treatment of these gastric ulcers with one of the three following treatment groups: esomeprazole 40 mg once daily; esomeprazole 20 mg once daily; or ranitidine 150 mg twice daily.

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A Comparative Efficacy and Safety Study of Nexium Delayed-Release Capsules (40mg qd and 20mg qd) Versus Ranitidine 150mg Bid for the Healing of NSAID-Associated Gastric Ulcers When Daily NSAID Use is Continued in Subjects in the US Only

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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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Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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1

20mg Oral tablet daily

Group Type EXPERIMENTAL

Esomeprazole

Intervention Type DRUG

20mg Oral tablet once daily

2

40mg oral tablet daily

Group Type EXPERIMENTAL

Esomeprazole

Intervention Type DRUG

40mg oral tablet once daily

3

150mg oral twice daily

Group Type ACTIVE_COMPARATOR

Ranitidine

Intervention Type DRUG

150mg oral twice daily

Interventions

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Esomeprazole

20mg Oral tablet once daily

Intervention Type DRUG

Ranitidine

150mg oral twice daily

Intervention Type DRUG

Esomeprazole

40mg oral tablet once daily

Intervention Type DRUG

Other Intervention Names

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Nexium Zantac Nexium

Eligibility Criteria

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Inclusion Criteria

1. A clinical diagnosis of a chronic condition (eg osteoarthritis or rheumatoid arthritis) that requires daily NSAID treatment for at least 2 months.

Exclusion Criteria

1. History of esophageal, gastric or duodenal surgery, except for simple closure of an ulcer.
2. History of severe liver disease, including (but not limited to) cirrhosis and acute or chronic hepatitis.
3. Other conditions and criteria, as specified in the protocol.
Minimum Eligible Age

18 Years

Eligible Sex

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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SH-NEN-0006

Identifier Type: -

Identifier Source: org_study_id

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