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.

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Key information

Conditions

Erosive Esophagitis Deglutition Disorders Digestive System Diseases Duodenal Diseases Esophageal Diseases Esophageal Motility Disorders Esophagitis Esophagitis, Peptic Gastroenteritis Gastroesophageal Reflux Gastroesophageal Reflux Disease Gastrointestinal Diseases Intestinal Diseases Peptic Ulcer Reflux Esophagitis Stomach Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Research Site, Alabaster, Alabama, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

esomeprazole magnesium (oral medication)

Drug

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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start: 2004
Study completion: 2005
First posted: Sep 21, 2005
Registry last updated: Mar 26, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed