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

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00644735

Collaborator

(none)

750

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Erosive Esophagitis	Drug: Esomeprazole Drug: Lansoprazole	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

750 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

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.

Study Start Date :

Dec 1, 2002

Actual Primary Completion Date :

Jan 1, 2004

Actual Study Completion Date :

Jan 1, 2004

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Nexium	Drug: Esomeprazole Other Names: Nexium
Active Comparator: 2 Prevacid	Drug: Lansoprazole Other Names: Prevacid

Arm

Intervention/Treatment

Experimental: 1

Nexium

Drug: Esomeprazole

Other Names:

Nexium

Active Comparator: 2

Prevacid

Drug: Lansoprazole

Other Names:

Prevacid

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.