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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00243724
First received: October 24, 2005
Last updated: March 25, 2009
Last verified: March 2009
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00243724     History of Changes
Other Study ID Numbers: D9612L00078
Study First Received: October 24, 2005
Last Updated: March 25, 2009
Health Authority: Canada: Health Canada

Keywords provided by AstraZeneca:
immunohistochemical
erosive esophagitis
Acid reflux disease

Additional relevant MeSH terms:
Dyspepsia
Gastroesophageal Reflux
Heartburn
Signs and Symptoms, Digestive
Signs and Symptoms
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on July 28, 2014