Prevention of Gastric Ulcers

March 12, 2009 updated by: AstraZeneca

A Comparative Efficacy and Safety Study of Nexium (Esomeprazole Magnesium) Delayed-Release Capsules (40mg qd and 20mg qd) Versus Placebo for the Prevention of Gastric Ulcers Associated With Daily NSAID Use in Patients at Risk

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

504

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.
  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: 3
Drug: Placebo
EXPERIMENTAL: 1
20mg oral daily
Drug: Esomeprazole
20mg oral daily
Other Names:
  • Nexium
Drug: Esomeprazole
40mg oral daily
Other Names:
  • Nexium
EXPERIMENTAL: 2
40mg oral daily
Drug: Esomeprazole
20mg oral daily
Other Names:
  • Nexium
Drug: Esomeprazole
40mg oral daily
Other Names:
  • Nexium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To assess the efficacy of esomeprazole 40 mg qd versus placebo and esomeprazole 20 mg qd versus placebo for up to 6 months of the treatment for the prevention of gastric (and/or duodenal) ulcers in patients receiving daily NSAID therapy and being at risk
Time Frame: Assessments at Week 0, Week 4, Week 12, Week 26
Assessments at Week 0, Week 4, Week 12, Week 26

Secondary Outcome Measures

Outcome Measure
Time Frame
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 20mg qd versus placebo in patients receiving daily NSAID therapy.
Time Frame: Assessments at Week 0, Week 4, Week 12, Week 26
Assessments at Week 0, Week 4, Week 12, Week 26
Safety and tolerability of esomeprazole 40 mg qd versus placebo and esomeprazole 20mg qd versus placebo for up to 6 months of treatment in patients receiving daily NSAID therapy
Time Frame: Assessments at Week 0, Week 4, Week 12, Week 26
Assessments at Week 0, Week 4, Week 12, Week 26

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: Professor Chris Hawkey, Queens Medical Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2001

Primary Completion (ACTUAL)

December 1, 2002

Study Completion (ACTUAL)

December 1, 2002

Study Registration Dates

First Submitted

February 27, 2008

First Submitted That Met QC Criteria

March 5, 2008

First Posted (ESTIMATE)

March 6, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

March 13, 2009

Last Update Submitted That Met QC Criteria

March 12, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SH-NEN-0013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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