HEARD (Long Term) Study - Histology of the Esophagus in Acid-Related Disease

Determine if different levels of acid-suppression with esomeprazole for 6 months on chosen histological markers of esophageal epithelial acid-related disease in patients with upper GI symptoms.

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Key information

Conditions

Gastroesophageal Reflux Deglutition Disorders Digestive System Diseases Dyspepsia Esophageal Diseases Esophageal Motility Disorders Gastrointestinal Diseases Heartburn Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Vancouver, British Columbia, Canada

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Signed informed consent
18 years or older
history of upper GI symptoms

Exclusion criteria

Peptic ulcer disease
upper gastrointestinal surgery
malignancy

Treatment and study plan

Esomeprazole

Drug

Primary outcomes

Change from baseline after 6 months in the level of ki-67 expression and histological markers of esophageal epithelial acid-related disease after acid-suppressive therapy with esomeprazole

Secondary outcomes

Changes in immunohistochemical markers of esophageal epithelial acid-related disease after 6 months treatment with different levels of acid suppression with esomeprazole

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

An Open-Label, Parallel-Group, Multi-Centre Study to Determine the Effect of Treatment With Esomeprazole for Six Months on Histological Markers of Esophageal Epithelial Acid-Related Disease in Patients With Upper GI Symptoms.

Important dates

Study start: 2005
Primary completion: 2007
Study completion: 2007
First posted: Oct 25, 2005
Registry last updated: Mar 26, 2009

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.

Published trials that share one or more normalized conditions with this study.

Completed