Barrett's Esophagus
Conditions
Keywords
Barrett's Esophagus
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
Interventions
DRUGEsomeprazole
DRUGLansoprazole
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United States
Outcome results
None listed