A Multicenter, Randomized, Double Blind, Double Dummy, Parallel-Group Efficacy Study Comparing 8 Weeks of Treatment With Esomeprazole Magnesium (40mg qd) to Lansoprazole (30mg qd) for the Healing of Erosive Esophagitis in Patients With Moderate or Severe Erosive Esophagitis

AstraZeneca

Status and phase: Completed; Phase 4

Conditions: Erosive Esophagitis

Treatments: Drug: Esomeprazole; Drug: Lansoprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT00641602

322

D9612L00046

Details and patient eligibility

About

This study looks at the healing rates in patients with Erosive Esophagitis (EE) when treated with either esomeprazole or lansoprazole

Enrollment: 1,000 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 Erosive Esophagitis within 1 week prior to starting 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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1,000 participants in 2 patient groups

1

Experimental group

Description:

Nexium

Treatment:

Drug: Esomeprazole

2

Active Comparator group

Description:

Prevacid

Treatment:

Drug: Lansoprazole