NEXIUM® in the Treatment of Moderate and Severe Erosive Esophagitis

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00206180

Enrollment

120

Registered

2005-09-21

Start date

2004-06-30

Completion date

2005-08-31

Last updated

2009-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erosive Esophagitis, Gastroesophageal Reflux Disease, Reflux Esophagitis

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.

Interventions

DRUGesomeprazole magnesium (oral medication)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Secondary outcomes and the relationship to pH will also be assessed.	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026