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OpenTrials
Completed

NCT Number: NCT00637559

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

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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Key information

Conditions

Barrett's Esophagus Barrett Esophagus Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Neoplasms Precancerous Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Esomeprazole Magnesium

Drug

Other names: Nexium

Primary outcomes

  1. 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 outcomes

  1. Compare total percent time distal esophageal pH is above 4.0 at steady state for each treatment period.

    Time frame: pH measured

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Multicenter, Double-blind, Three-way Crossover Intraesophageal and Intragastric pH Study of Three Esomeprazole Treatment Regimens in Documented Barrett's Esophagus Patients

Important dates

Study start
2002
Primary completion
2003
Study completion
2003
First posted
Mar 18, 2008
Registry last updated
Jan 25, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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