NEXIUM® in the Treatment of Moderate and Severe Erosive Esophagitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00206180
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : March 26, 2009
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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.

Condition or disease Intervention/treatment Phase
Erosive Esophagitis Reflux Esophagitis Gastroesophageal Reflux Disease Drug: esomeprazole magnesium (oral medication) Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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 Start Date : June 2004
Study Completion Date : August 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  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 Outcome Measures :
  1. Secondary outcomes and the relationship to pH will also be assessed.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00206180

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Sponsors and Collaborators
Study Director: Nexium Medical Science Director, MD AstraZeneca

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00206180     History of Changes
Other Study ID Numbers: D9612L00062
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: March 26, 2009
Last Verified: March 2009

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophagitis, Peptic
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases
Stomach Diseases
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action