NEXIUM® in the Treatment of Moderate and Severe Erosive Esophagitis


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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Masking: Double


  • Drug: esomeprazole magnesium (oral medication)

Clinical Trial Outcome Measures

Primary 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 Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • AstraZeneca
  • Overall Official(s)
    • Nexium Medical Science Director, MD, Study Director, AstraZeneca

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