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

AstraZeneca80 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Barrett's Esophagus

Interventions

EsomeprazoleDRUG

LansoprazoleDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (12)

Research Site

Phoenix, Arizona, United States

Research Site

Tucson, Arizona, United States

Research Site

North Chicago, Illinois, United States

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

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