Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Group Comparison of the Remission Rates of Once Daily Treatment With Esomeprazole 20mg and Lansoprazole 15mg for 6 Months in Patients Whose EE Has Been Healed

Phase 4

Completed

• Conditions: Erosive Esophagitis
• Interventions: Drug: Esomeprazole; Drug: Lansoprazole

• Registration Number: NCT00644735
• Lead Sponsor: AstraZeneca

Brief Summary

A study to look at the rates of remission (non re-appearance of erosive esomeprazole) when treated with esomeprazole or lansoprazole; in patients in with erosive esomeprazole (EE) that is in remission (i.e. previously healed EE).

Detailed Description

Not available

Study Timeline

• Study Start: 2002-12
• Primary Completion: 2004-01
• Study Completion: 2004-01
• Study First Submitted: 2008-03-18
• Study First Submitted QC: 2008-03-21
• Study First Posted: 2008-03-27
• Status Verified: 2009-03
• Last Update Submitted: 2009-03-25
• Last Update Posted: 2009-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 750

Inclusion Criteria

• Episodes of heartburn (described as a burning feeling rising from the stomach or lower part of the chest up towards the neck) for 2 days or more during the last 7 days prior to baseline
• Confirmed diagnosis of Erosive Esophagus, patients must undergo an endoscopy before entering the study.

Exclusion Criteria

• Any signs of gastrointestinal bleeding at the time of the starting the study.
• Any previous gastric or esophageal surgery.
• Various gastrointestinal diseases as listed in the protocol.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Esomeprazole	Nexium
2	Lansoprazole	Prevacid

Primary Outcome Measures

Name	Time	Method
To compare rates of remission (non re-appearance of erosive esomeprazole) when treated with esomeprazole or lansoprazole; in patients in with erosive esomeprazole (EE) that is in remission (i.e. previously healed EE).	Symptoms will be assessed by the investigator at each visit and the patients will undergo an endoscopy at Months 3 and 6

Secondary Outcome Measures

Name	Time	Method
To compare endoscopic remission rates through 6 months of treatment with E20 and L15, after initial healing of EE.	Symptoms will be assessed by the investigator at each visit and the patients will undergo an endoscopy at Months 3 and 6
The assessment of symptoms in the two treatment groups after 1, 3 and 6 months.	patients will undergo an endoscopy at Months 3 and 6
To assess the safety and tolerability of up to 6 months of treatment with E20 and L15 after initial healing of EE.	Symptoms will be assessed by the investigator at each visit and the patients will undergo an endoscopy at Months 3 and 6