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

AstraZeneca750 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

750

Conditions

Erosive Esophagitis

Interventions

EsomeprazoleDRUG

LansoprazoleDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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).

Time frame: Symptoms will be assessed by the investigator at each visit and the patients will undergo an endoscopy at Months 3 and 6

Secondary Outcomes

To compare endoscopic remission rates through 6 months of treatment with E20 and L15, after initial healing of EE.

Time frame: 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.

Time frame: 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.

Time frame: Symptoms will be assessed by the investigator at each visit and the patients will undergo an endoscopy at Months 3 and 6

Data from ClinicalTrials.gov

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