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

January 24, 2011 updated by: AstraZeneca

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
40mg twice daily
Drug: Esomeprazole Magnesium
Other Names:
  • Nexium
Experimental: 2
40mg three times daily
Drug: Esomeprazole Magnesium
Other Names:
  • Nexium
Experimental: 3
20mg three times daily
Drug: Esomeprazole Magnesium
Other Names:
  • Nexium

What is the study measuring?

Primary Outcome Measures

Outcome 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.
Time Frame: pH measured on Day 5
pH measured on Day 5

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2002

Primary Completion (Actual)

April 1, 2003

Study Completion (Actual)

April 1, 2003

Study Registration Dates

First Submitted

March 11, 2008

First Submitted That Met QC Criteria

March 11, 2008

First Posted (Estimate)

March 18, 2008

Study Record Updates

Last Update Posted (Estimate)

January 25, 2011

Last Update Submitted That Met QC Criteria

January 24, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 315
  • D9612L00056

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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