NEXIUM® in the Treatment of Moderate and Severe Erosive Esophagitis

Phase 4CompletedNCT00206180

AstraZeneca120 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

DOUBLE

Enrollment

120

Conditions

Erosive Esophagitis Reflux Esophagitis Gastroesophageal Reflux Disease

Interventions

esomeprazole magnesium (oral medication)DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (39)

Outcomes

Primary Outcomes

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

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

Data from ClinicalTrials.gov

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Research Site

Alabaster, Alabama, United States

Research Site

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

Bridgeport, Connecticut, United States

Research Site

Fort Lauderdale, Florida, United States

Research Site

Hialeah, Florida, United States

Research Site

Jacksonville, Florida, United States

...and 29 more locations