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.
Full Title of Study: “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 Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double
- Drug: esomeprazole magnesium (oral medication)
Clinical Trial Outcome Measures
- 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 and the relationship to pH will also be assessed.
Participating in This Clinical Trial
- 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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 75 Years
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Overall Official(s)
- Nexium Medical Science Director, MD, Study Director, AstraZeneca
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