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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00243724
First Posted: October 25, 2005
Last Update Posted: March 26, 2009
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.
Information provided by:
AstraZeneca
  Purpose
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 Intervention Phase
Gastroesophageal Reflux Heartburn Dyspepsia Drug: Esomeprazole Phase 3

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

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

Estimated Enrollment: 350
Study Start Date: April 2005
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

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

Exclusion Criteria:

  • Peptic ulcer disease
  • upper gastrointestinal surgery
  • malignancy
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00243724


Locations
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
Canada
Research Site
Quebec, Canada
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca Canada Medical Director, MD AstraZeneca
  More Information

ClinicalTrials.gov Identifier: NCT00243724     History of Changes
Other Study ID Numbers: D9612L00078
First Submitted: October 24, 2005
First Posted: October 25, 2005
Last Update Posted: March 26, 2009
Last Verified: March 2009

Keywords provided by AstraZeneca:
immunohistochemical
erosive esophagitis
Acid reflux disease

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