NEXIUM® in the Treatment of Moderate and Severe Erosive Esophagitis

Phase 4

Completed

• Conditions: Erosive Esophagitis; Reflux Esophagitis; Gastroesophageal Reflux Disease

• Registration Number: NCT00206180
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-06
• Study Completion: 2005-08
• Study First Submitted: 2005-09-15
• Study First Submitted QC: 2005-09-15
• Study First Posted: 2005-09-21
• Status Verified: 2009-03
• Last Update Submitted: 2009-03-25
• Last Update Posted: 2009-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Secondary outcomes and the relationship to pH will also be assessed.

Trial Locations

Locations (1)

Research Site; 🇺🇸 Milwaukee, Wisconsin, United States