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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00243724
Recruitment Status : Completed
First Posted : October 25, 2005
Last Update Posted : March 26, 2009
Information provided by:

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Gastroesophageal Reflux Heartburn Dyspepsia Drug: Esomeprazole Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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.
Study Start Date : April 2005
Actual Primary Completion Date : June 2007
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Changes in immunohistochemical markers of esophageal epithelial acid-related disease after 6 months treatment with different levels of acid suppression with esomeprazole

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • Peptic ulcer disease
  • upper gastrointestinal surgery
  • malignancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00243724

Canada, British Columbia
Research Site
Vancouver, British Columbia, Canada
Canada, Nova Scotia
Research Site
Halifax, Nova Scotia, Canada
Canada, Ontario
Research Site
Guelph, Ontario, Canada
Research Site
Hamilton, Ontario, Canada
Research Site
Kingston, Ontario, Canada
Research Site
Mississauga, Ontario, Canada
Research Site
North York, Ontario, Canada
Canada, Quebec
Research Site
Montreal, Quebec, Canada
Research Site
Pointe-Claire, Quebec, Canada
Research Site
Quebec, Canada
Sponsors and Collaborators
Study Director: AstraZeneca Canada Medical Director, MD AstraZeneca Identifier: NCT00243724     History of Changes
Other Study ID Numbers: D9612L00078
First Posted: October 25, 2005    Key Record Dates
Last Update Posted: March 26, 2009
Last Verified: March 2009

Keywords provided by AstraZeneca:
erosive esophagitis
Acid reflux disease

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action