NEXIUM® in the Treatment of Moderate and Severe Erosive Esophagitis
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
1 other identifier
interventional
120
1 country
39
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jun 2004
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 15, 2005
CompletedFirst Posted
Study publicly available on registry
September 21, 2005
CompletedMarch 26, 2009
March 1, 2009
September 15, 2005
March 25, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Secondary outcomes and the relationship to pH will also be assessed.
Interventions
Eligibility Criteria
You may qualify if:
- Male or non-pregnant, non-lactating female patients between the ages of 18 and 75 years
- Patients must have moderate to severe erosive esophagitis
You may not qualify if:
- Significant gastrointestinal bleeding
- Severe heart, lung, liver or kidney disease
- Esophagitis not related to acid reflux
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (39)
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
Related Publications (1)
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.
PMID: 17305763DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Nexium Medical Science Director, MD
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 15, 2005
First Posted
September 21, 2005
Study Start
June 1, 2004
Study Completion
August 1, 2005
Last Updated
March 26, 2009
Record last verified: 2009-03