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

AstraZeneca

Status and phase: Completed; Phase 4

Conditions: Erosive Esophagitis

Treatments: Drug: Esomeprazole; Drug: Lansoprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT00644735

325

D9612L00048

Details and patient eligibility

About

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).

Enrollment: 750 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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.

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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750 participants in 2 patient groups

1

Experimental group

Description:

Nexium

Treatment:

Drug: Esomeprazole

2

Active Comparator group

Description:

Prevacid

Treatment:

Drug: Lansoprazole