NEXIUM® in the Treatment of Moderate and Severe Erosive Esophagitis

Condition(s) targeted: Erosive Esophagitis; Reflux Esophagitis; Gastroesophageal Reflux Disease

Intervention: esomeprazole magnesium (oral medication) (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Nexium Medical Science Director, MD, Study Director, Affiliation: AstraZeneca

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.

Official title: 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

Study design: Educational/Counseling/Training, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Pharmacodynamics Study

Primary outcome: 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: Secondary outcomes and the relationship to pH will also be assessed.

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

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

Research Site, Alabaster, Alabama, United States

Research Site, Dinuba, California, United States

Research Site, Fresno, California, United States

Research Site, Orange, California, United States

Research Site, Anaheim, California, United States

Research Site, San Diego, California, United States

Research Site, Bridgeport, Connecticut, United States

Research Site, Miami, Florida, United States

Research Site, Hialeah, Florida, United States

Research Site, Jacksonville, Florida, United States

Research Site, Zephyr Hills, Florida, United States

Research Site, Fort Lauderdale, Florida, United States

Research Site, New Port Richey, Florida, United States

Research Site, Rome, Georgia, United States

Research Site, Decatur, Georgia, United States

Research Site, Savannah, Georgia, United States

Research Site, Urbana, Illinois, United States

Research Site, Oakbrook Terrace, Illinois, United States

Research Site, Louisville, Kentucky, United States

Research Site, Covington, Louisiana, United States

Research Site, Baltimore, Maryland, United States

Research Site, Chevy Chase, Maryland, United States

Research Site, Troy, Michigan, United States

Research Site, Kalamazoo, Michigan, United States

Research Site, Passaic, New Jersey, United States

Research Site, Egg Harbor Township, New Jersey, United States

Research Site, Brooklyn, New York, United States

Research Site, New York, New York, United States

Research Site, Chapel Hill, North Carolina, United States

Research Site, Jacksonville, North Carolina, United States

Research Site, Duncansville, Pennsylvania, United States

Research Site, Pittsburgh, Pennsylvania, United States

Research Site, N Providence, Rhode Island, United States

Research Site, Knoxville, Tennessee, United States

Research Site, Dallas, Texas, United States

Research Site, Ogden, Utah, United States

Research Site, Spokane, Washington, United States

Research Site, Bellevue, Washington, United States

Research Site, Milwaukee, Wisconsin, United States

Starting date: June 2004
Last updated: June 21, 2006