An Open Label pH Comparison of Esomeprazole and Lansoprazole in Barrett's Esophagus Patients
Phase 4
Completed
- Conditions
- Barrett's Esophagus
- Registration Number
- NCT00352261
- Lead Sponsor
- AstraZeneca
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (2)
Research Site
🇺🇸Norfolk, Virginia, United States
Research SIte
🇺🇸Springfield, Missouri, United States