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Ulcer Prevention II

Primary Purpose

NSAID Associated Gastric Ulcers

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Esomeprazole
Esomeprazole
Placebo
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

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:

  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.
  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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    1

    2

    3

    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

    First Posted
    February 27, 2008
    Last Updated
    January 24, 2011
    Sponsor
    AstraZeneca
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    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
    1
    Arm Type
    Experimental
    Arm Description
    20mg capsule once daily
    Arm Title
    2
    Arm Type
    Experimental
    Arm Description
    40mg capsule daily
    Arm Title
    3
    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
    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.
    Time Frame
    Assessments at Week 0, Week 4, Week 12, Week 26
    Secondary Outcome Measure Information:
    Title
    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.
    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
    No
    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

    Learn more about this trial

    Ulcer Prevention II

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