An Open Label pH Comparison of Esomeprazole and Lansoprazole in Barrett's Esophagus Patients

This study has been completed.

First Received: July 12, 2006 Last Updated: March 25, 2009 History of Changes

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00352261

Purpose

The purpose of the study is to compare the treatment of esomeprazole 40 mg once daily and lansoprazole 30 mg once daily in controlling intragastric pH in Barrett's Esophagus patients

Condition	Intervention	Phase
Barrett's Esophagus	Drug: Esomeprazole Drug: Lansoprazole	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Pharmacodynamics Study
Official Title:	An Open-Label, 2-Way Crossover Study of Steady-State Intragastric pH Control Comparing 2 Dosage Regimens of Esomeprazole and Lansoprazole in Barrett's Esophagus Patients

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:

Compare pharmacodynamic efficacy of esomeprazole 40 mg & lansoprazole 30 mg once daily in controlling intragastric pH in Barrett's Esophagus patients by evaluation of the percentage of time that intragastric pH is >4.0 over a 24 hr period steady state

Secondary Outcome Measures:

Compare pharmacodynamic efficacy of esomeprazole 40 mg & lansoprazole 30 mg bid in controlling intragastric pH in BE patients by evaluation of the % of time intragastric pH is >4.0 over 24 hr period at steady state

Estimated Enrollment:	80
Study Start Date:	January 2006
Study Completion Date:	April 2007

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Documented history (within 2 yrs of histologically proven BE;
Aged 18-70 (inclusive);
Willing and able to comply with all study procedures

Exclusion Criteria:

Signs of clinically significant GI bleeding within 3 days prior to randomization;
History of gastric or esophageal surgery;
Clinically significant illness within 2 weeks prior to first dose of study drug or during study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00352261

Locations

United States, Arizona
Research Site
Phoenix, Arizona, United States
Research Site
Tucson, Arizona, United States
United States, Illinois
Research Site
North Chicago, Illinois, United States
United States, Minnesota
Research Site
Rochester, Minnesota, United States
United States, Missouri
Research Site
Kansas City, Missouri, United States
Research SIte
Springfield, Missouri, United States
United States, Montana
Research Site
Butte, Montana, United States
United States, Ohio
Research Site
Cleveland, Ohio, United States
United States, Pennsylvania
Research Site
Philadelphia, Pennsylvania, United States
United States, Tennessee
Research Site
Knoxville, Tennessee, United States
United States, Texas
Research Site
Dallas, Texas, United States
United States, Virginia
Research Site
Norfolk, Virginia, United States

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Debra Silberg, MD

AstraZeneca

More Information

No publications provided

Study ID Numbers:	D9612L00082
Study First Received:	July 12, 2006
Last Updated:	March 25, 2009
ClinicalTrials.gov Identifier:	NCT00352261 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Barrett's Esophagus

Additional relevant MeSH terms:

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

Digestive System Abnormalities
Digestive System Diseases
Therapeutic Uses
Anti-Ulcer Agents
Barrett Esophagus
Esophageal Diseases
Lansoprazole

ClinicalTrials.gov processed this record on February 08, 2010