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

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.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00641602

Enrollment

1000

Registered

2008-03-24

Start date

2002-12-31

Completion date

2003-08-31

Last updated

2009-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erosive Esophagitis

Keywords

Erosive Esophagitis, Nexium, Heartburn

Brief summary

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

Interventions

DRUGEsomeprazole

40mg once daily

DRUGLansoprazole

30mg once daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026