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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-03-31

Study Completion Date

2003-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Barrett's Esophagus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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1

40mg twice daily

Group Type EXPERIMENTAL

Esomeprazole Magnesium

Intervention Type DRUG

2

40mg three times daily

Group Type EXPERIMENTAL

Esomeprazole Magnesium

Intervention Type DRUG

3

20mg three times daily

Group Type EXPERIMENTAL

Esomeprazole Magnesium

Intervention Type DRUG

Interventions

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Esomeprazole Magnesium

Intervention Type DRUG

Other Intervention Names

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Nexium

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No