NEXIUM® in the Treatment of Moderate and Severe Erosive Esophagitis

March 25, 2009 updated by: AstraZeneca

A Multicenter, Double-Blind, Randomized Trial of the Relationship of Intragastric Acid Control and Healing Status of Moderate and Severe Erosive Esophagitis After Treatment With Esomeprazole Magnesium (NEXIUM®) 10 mg and 40 mg Once Daily

The purpose of this study is to decide if controlling stomach acid is related to healing of erosive esophagitis after treatment with esomeprazole magnesium (NEXIUM®) 10 mg and 40 mg once daily.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Alabaster, Alabama, United States
        • Research Site
    • California
      • Anaheim, California, United States
        • Research Site
      • Dinuba, California, United States
        • Research Site
      • Fresno, California, United States
        • Research Site
      • Orange, California, United States
        • Research Site
      • San Diego, California, United States
        • Research Site
    • Connecticut
      • Bridgeport, Connecticut, United States
        • Research Site
    • Florida
      • Fort Lauderdale, Florida, United States
        • Research Site
      • Hialeah, Florida, United States
        • Research Site
      • Jacksonville, Florida, United States
        • Research Site
      • Miami, Florida, United States
        • Research Site
      • New Port Richey, Florida, United States
        • Research Site
      • Zephyr Hills, Florida, United States
        • Research Site
    • Georgia
      • Decatur, Georgia, United States
        • Research Site
      • Rome, Georgia, United States
        • Research Site
      • Savannah, Georgia, United States
        • Research Site
    • Illinois
      • Oakbrook Terrace, Illinois, United States
        • Research Site
      • Urbana, Illinois, United States
        • Research Site
    • Kentucky
      • Louisville, Kentucky, United States
        • Research Site
    • Louisiana
      • Covington, Louisiana, United States
        • Research Site
    • Maryland
      • Baltimore, Maryland, United States
        • Research Site
      • Chevy Chase, Maryland, United States
        • Research Site
    • Michigan
      • Kalamazoo, Michigan, United States
        • Research Site
      • Troy, Michigan, United States
        • Research Site
    • New Jersey
      • Egg Harbor Township, New Jersey, United States
        • Research Site
      • Passaic, New Jersey, United States
        • Research Site
    • New York
      • Brooklyn, New York, United States
        • Research Site
      • New York, New York, United States
        • Research Site
    • North Carolina
      • Chapel Hill, North Carolina, United States
        • Research Site
      • Jacksonville, North Carolina, United States
        • Research Site
    • Pennsylvania
      • Duncansville, Pennsylvania, United States
        • Research Site
      • Pittsburgh, Pennsylvania, United States
        • Research Site
    • Rhode Island
      • N Providence, Rhode Island, United States
        • Research Site
    • Tennessee
      • Knoxville, Tennessee, United States
        • Research Site
    • Texas
      • Dallas, Texas, United States
        • Research Site
    • Utah
      • Ogden, Utah, United States
        • Research Site
    • Washington
      • Bellevue, Washington, United States
        • Research Site
      • Spokane, Washington, United States
        • Research Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States
        • Research Site

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 to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or non-pregnant, non-lactating female patients between the ages of 18 and 75 years
  • Patients must have moderate to severe erosive esophagitis

Exclusion Criteria:

  • Significant gastrointestinal bleeding
  • Severe heart, lung, liver or kidney disease
  • Esophagitis not related to acid reflux

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

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To determine the relationship between 24-hour intragastric pH at Day 5 and healing status of moderate to severe erosive esophagitis, after 4 weeks of treatment with 2 doses of esomeprazole magnesium.

Secondary Outcome Measures

Outcome Measure
Secondary outcomes and the relationship to pH will also be assessed.

Collaborators and Investigators

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

Sponsor

AstraZeneca

Investigators

  • Study Director: Nexium Medical Science Director, MD, AstraZeneca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

June 1, 2004

Study Completion (Actual)

August 1, 2005

Study Registration Dates

First Submitted

September 15, 2005

First Submitted That Met QC Criteria

September 15, 2005

First Posted (Estimate)

September 21, 2005

Study Record Updates

Last Update Posted (Estimate)

March 26, 2009

Last Update Submitted That Met QC Criteria

March 25, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D9612L00062

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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