Overview

Barrett's Esophagus - 315 - 3 Way Cross-Over

Status:
Completed
Trial end date:
2003-04-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
AstraZeneca
Treatments:
Esomeprazole
Criteria
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.