Barrett's Esophagus
Conditions
Keywords
Nexium, Barrett's esophagus
Brief summary
This study looks the intragastric and intraesophageal pH in patients with documented Barrett's esophagus whilst taking esomeprazole 40mg twice daily, esomeprazole 40mg three times daily, esomeprazole 20 mg three times daily.
Interventions
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Must have a previously established, biopsy-proven diagnosis of Barrett's esophagus with segment length greater than 3cm, with no dysplasia or adenocarcinoma within the previous 12 months
Exclusion criteria
* A history of esophageal, gastric, or duodenal surgery, including anti-reflux surgery or endoscopic anti-reflux procedures, except for simple closure of a gastric or duodenal ulcer. * History of various gastrointestinal diseases - please see investigator for full list. * Evidence of any malignant disease in the last 5 years, except minor superficial skin disease. * Unstable diabetes mellitus. Stable on a controlled diet, oral agents or insulin are acceptable.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the total percent time during the 24-hour monitoring period that gastric pH is above 4.0 at steady state in patients when taking: esomeprazole 40mg twice daily, esomeprazole 40mg three times daily, esomeprazole 20 mg three times daily. | pH measured on Day 5 |
Secondary
| Measure | Time frame |
|---|---|
| Compare total percent time distal esophageal pH is above 4.0 at steady state for each treatment period. | pH measured |
Outcome results
None listed