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 - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00644735

Purpose

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).

Condition	Intervention	Phase
Erosive Esophagitis	Drug: Esomeprazole Drug: Lansoprazole	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
Official Title:	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.

Resource links provided by NLM:

Drug Information available for: Omeprazole Omeprazole magnesium Lansoprazole Esomeprazole Sodium Esomeprazole magnesium

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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). [ Time Frame: Symptoms will be assessed by the investigator at each visit and the patients will undergo an endoscopy at Months 3 and 6 ]

Secondary Outcome Measures:

To compare endoscopic remission rates through 6 months of treatment with E20 and L15, after initial healing of EE. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: Symptoms will be assessed by the investigator at each visit and the patients will undergo an endoscopy at Months 3 and 6 ]

Estimated Enrollment:	750
Study Start Date:	December 2002
Study Completion Date:	January 2004
Primary Completion Date:	January 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Nexium	Drug: Esomeprazole
2: Active Comparator Prevacid	Drug: Lansoprazole

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00644735

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Paula Fernstrom

Nexium Global Product Director, AstraZeneca

More Information

No publications provided

Responsible Party:	Astra Zeneca ( Tore Lind, MD - Nexium Medical Science Director )
Study ID Numbers:	325, D9612L00048
Study First Received:	March 18, 2008
Last Updated:	March 25, 2009
ClinicalTrials.gov Identifier:	NCT00644735 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Erosive Esophagitis
Nexium
Esomeprazole
Lansoprazole
Heartburn

Additional relevant MeSH terms:

Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Gastrointestinal Agents
Omeprazole
Enzyme Inhibitors
Pharmacologic Actions

Esophagitis
Digestive System Diseases
Therapeutic Uses
Anti-Ulcer Agents
Esophageal Diseases
Lansoprazole
Gastroenteritis

ClinicalTrials.gov processed this record on February 08, 2010