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

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.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00644735

Enrollment

750

Registered

2008-03-27

Start date

2002-12-31

Completion date

2004-01-31

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, Esomeprazole, Lansoprazole, Heartburn

Brief summary

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).

Interventions

DRUGEsomeprazole

DRUGLansoprazole

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 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.

Design outcomes

Primary

Measure	Time frame
To compare 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).	Symptoms will be assessed by the investigator at each visit and the patients will undergo an endoscopy at Months 3 and 6

Secondary

Measure	Time frame
To compare endoscopic remission rates through 6 months of treatment with E20 and L15, after initial healing of EE.	Symptoms will be assessed by the investigator at each visit and the patients will undergo an endoscopy at Months 3 and 6
The assessment of symptoms in the two treatment groups after 1, 3 and 6 months.	patients will undergo an endoscopy at Months 3 and 6
To assess the safety and tolerability of up to 6 months of treatment with E20 and L15 after initial healing of EE.	Symptoms will be assessed by the investigator at each visit and the patients will undergo an endoscopy at Months 3 and 6

Outcome results

None listed

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