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”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Crossover Assignment, Pharmacodynamics Study

Study Primary Completion Date: April 2003

Intervention(s) in this Clinical Trial

• Drug: Esomeprazole Magnesium

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • 40mg twice daily
• Experimental: 2
  • 40mg three times daily
• Experimental: 3
  • 20mg three times daily

Primary Measures

• 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.
  • Time Frame: pH measured on Day 5
    

Secondary Measures

• Compare total percent time distal esophageal pH is above 4.0 at steady state for each treatment period.
  • Time Frame: pH measured
    

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: AstraZeneca

Overall Clinical Trial Officials and Contacts

Paula Fernstrom Study Director Nexium Global Product Director, AstraZeneca  

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00637559

Study ID Number: 315

ClinicalTrials.gov Identifier: NCT00637559

Health Authority: United States: Food and Drug Administration