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Ulcer Prevention II

Primary Purpose

NSAID Associated Gastric Ulcers

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Esomeprazole

Placebo

About this trial

This is an interventional prevention trial for NSAID Associated Gastric Ulcers focused on measuring NSAID, Nexium, esomeprazole, Gastric Ulcers

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

No active/current gastric or duodenal ulcer on baseline endoscopy.
A clinical diagnosis of a chronic condition that requires daily NSAID treatment for at least 6 months.
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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

20mg capsule once daily

40mg capsule daily

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT00629928

First Posted

February 27, 2008

Last Updated

January 24, 2011

Sponsor

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT00629928

Brief Title

Ulcer Prevention II

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2011

Overall Recruitment Status

Completed

Study Start Date

February 2001 (undefined)

Primary Completion Date

March 2003 (Actual)

Study Completion Date

March 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

AstraZeneca

4. Oversight

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

NSAID Associated Gastric Ulcers

Keywords

NSAID, Nexium, esomeprazole, Gastric Ulcers

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

20mg capsule once daily

Arm Title

Arm Type

Experimental

Arm Description

40mg capsule daily

Arm Title

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Esomeprazole

Other Intervention Name(s)

Nexium

Intervention Description

20mg oral capsule daily

Intervention Type

Drug

Intervention Name(s)

Esomeprazole

Other Intervention Name(s)

Nexium

Intervention Description

40mg oral capsule daily

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Time Frame

Assessments at Week 0, Week 4, Week 12, Week 26

Secondary Outcome Measure Information:

Title

Time Frame

Assessments at Week 0, Week 4, Week 12, Week 26

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: No active/current gastric or duodenal ulcer on baseline endoscopy. A clinical diagnosis of a chronic condition that requires daily NSAID treatment for at least 6 months. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Paula Fernstrom

Organizational Affiliation

Nexium Global Product Director, AstraZeneca

Official's Role

Study Director

12. IPD Sharing Statement

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Ulcer Prevention II

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