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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

750 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-12-31

Study Completion Date

2004-01-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Erosive Esophagitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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1

Nexium

Group Type EXPERIMENTAL

Esomeprazole

Intervention Type DRUG

2

Prevacid

Group Type ACTIVE_COMPARATOR

Lansoprazole

Intervention Type DRUG

Interventions

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Esomeprazole

Intervention Type DRUG

Lansoprazole

Intervention Type DRUG

Other Intervention Names

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Nexium Prevacid

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No