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

Barrett's Esophagus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00637559
• Other study ID #: 315
• Secondary ID: D9612L00056
• Status: Completed
• Phase: Phase 4
• First received: March 11, 2008
• Last updated: January 24, 2011
• Start date: March 2002
• Est. completion date: April 2003

Study information

• Verified date: January 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 2003
• Est. primary completion date: April 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Barrett Esophagus
• Barrett's Esophagus

Intervention

Drug:
• Esomeprazole Magnesium

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Compare total percent time distal esophageal pH is above 4.0 at steady state for each treatment period.		pH measured