Barrett's Esophagus - 315 - 3 Way Cross-Over
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Barrett's Esophagus
Intervention: Esomeprazole Magnesium (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
Paula Fernstrom, Study Director, Affiliation: Nexium Global Product Director, AstraZeneca
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.
Clinical Details
Official title: A Multicenter, Double-Blind, Three-Way Crossover Intraesophageal and Intragastric pH Study of Three Esomeprazole Treatment Regimens in Documented Barrett's Esophagus Patients
Study design: Treatment, Randomized, Double-Blind, Crossover Assignment, Pharmacodynamics Study
Primary outcome: 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.
Secondary outcome: Compare total percent time distal esophageal pH is above 4.0 at steady state for each treatment period.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Additional Information
Starting date: March 2002
Ending date: May 2003
Last updated: March 11, 2008
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