NEXIUM® in the Treatment of Moderate and Severe Erosive Esophagitis

NCT ID: NCT00206180

Last Updated: 2009-03-26

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

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2005-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Erosive Esophagitis Reflux Esophagitis Gastroesophageal Reflux Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Interventions

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esomeprazole magnesium (oral medication)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Principal Investigators

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Nexium Medical Science Director, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research Site

Alabaster, Alabama, United States

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Anaheim, California, United States

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Dinuba, California, United States

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Fresno, California, United States

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Orange, California, United States

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San Diego, California, United States

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Bridgeport, Connecticut, United States

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Fort Lauderdale, Florida, United States

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Hialeah, Florida, United States

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Jacksonville, Florida, United States

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Miami, Florida, United States

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New Port Richey, Florida, United States

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Zephyrhills, Florida, United States

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Decatur, Georgia, United States

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Rome, Georgia, United States

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Savannah, Georgia, United States

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Oakbrook Terrace, Illinois, United States

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Urbana, Illinois, United States

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Louisville, Kentucky, United States

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Covington, Louisiana, United States

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Baltimore, Maryland, United States

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Chevy Chase, Maryland, United States

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Kalamazoo, Michigan, United States

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Troy, Michigan, United States

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Egg Harbor, New Jersey, United States

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Passaic, New Jersey, United States

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Brooklyn, New York, United States

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New York, New York, United States

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Chapel Hill, North Carolina, United States

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Jacksonville, North Carolina, United States

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Duncansville, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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North Providence, Rhode Island, United States

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Knoxville, Tennessee, United States

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Dallas, Texas, United States

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Ogden, Utah, United States

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Bellevue, Washington, United States

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Spokane, Washington, United States

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Milwaukee, Wisconsin, United States

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Countries

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United States

References

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Katz PO, Ginsberg GG, Hoyle PE, Sostek MB, Monyak JT, Silberg DG. Relationship between intragastric acid control and healing status in the treatment of moderate to severe erosive oesophagitis. Aliment Pharmacol Ther. 2007 Mar 1;25(5):617-28. doi: 10.1111/j.1365-2036.2006.03235.x.

Reference Type DERIVED
PMID: 17305763 (View on PubMed)

Other Identifiers

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D9612L00062

Identifier Type: -

Identifier Source: org_study_id

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