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

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00641602

Collaborator

(none)

1,000

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief Summary

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

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1000 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

Official Title:

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.

Study Start Date :

Dec 1, 2002

Actual Primary Completion Date :

Aug 1, 2003

Actual Study Completion Date :

Aug 1, 2003

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Nexium	Drug: Esomeprazole 40mg once daily Other Names: Nexium
Active Comparator: 2 Prevacid	Drug: Lansoprazole 30mg once daily Other Names: Prevacid

Arm

Intervention/Treatment

Experimental: 1

Nexium

Drug: Esomeprazole

40mg once daily

Other Names:

Nexium

Active Comparator: 2

Prevacid

Drug: Lansoprazole

30mg once daily

Other Names:

Prevacid

Outcome Measures

Primary Outcome Measures

To compare the difference in healing rates of erosive esophagitis (EE) between esomeprazole 40 mg qd (E40) and lansoprazole 30 mg qd (L30) in patients with moderate or severe EE, defined as Grade C or D in the Los Angeles (LA) Classification scale. [Esophagogastroduodenoscopy (EGD) at baseline and then week 4 and week 8 (if not healed at week 4)]

Secondary Outcome Measures

1. To compare the difference in the resolution of, and relief of, the investigator evaluated GERD symptoms of heartburn, acid regurgitation, dysphagia, and epigastric pain between E40 and L30 at week 4 of treatment in patients with moderate or severe EE. [Esophagogastroduodenoscopy (EGD) at baseline and then week 4 and week 8 (if not healed at week 4)]
1. To compare the difference between E40 and L30 in the occurrence of heartburn symptoms as reported in the patient's daily diary. [Dairy card to be completed by patient daily]
To evaluate safety and tolerability of E40 compared to that of L30 in patients with moderate or severe EE. [Adverse event collection on an ongoing basis]

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 Erosive Esophagitis within 1 week prior to starting the study.