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

Phase 4

Completed

• Conditions: Erosive Esophagitis
• Interventions: Drug: Esomeprazole; Drug: Lansoprazole

• Registration Number: NCT00641602
• Lead Sponsor: AstraZeneca

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2002-12
• Primary Completion: 2003-08
• Study Completion: 2003-08
• Study First Submitted: 2008-03-18
• Study First Submitted QC: 2008-03-21
• Study First Posted: 2008-03-24
• Status Verified: 2009-03
• Last Update Submitted: 2009-03-25
• Last Update Posted: 2009-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Esomeprazole	Nexium
2	Lansoprazole	Prevacid

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)
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
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