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NCT00243724 Clinical Trial

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

Gastroesophageal Reflux Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00243724
Other study ID # D9612L00078
Secondary ID
Status Completed
Phase Phase 3
First received October 24, 2005
Last updated March 25, 2009
Start date April 2005
Est. completion date June 2007

Study information
Verified date March 2009
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 350
Est. completion date June 2007
Est. primary completion date June 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Signed informed consent

- 18 years or older

- history of upper GI symptoms

Exclusion Criteria:

- Peptic ulcer disease

- upper gastrointestinal surgery

- malignancy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Esomeprazole

Locations
Country Name City State
Canada Research Site Guelph Ontario
Canada Research Site Halifax Nova Scotia
Canada Research Site Hamilton Ontario
Canada Research Site Kingston Ontario
Canada Research Site Mississauga Ontario
Canada Research Site Montreal Quebec
Canada Research Site North York Ontario
Canada Research Site Pointe-Claire Quebec
Canada Research Site Quebec
Canada Research Site Vancouver British Columbia

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Changes in immunohistochemical markers of esophageal epithelial acid-related disease after 6 months treatment with different levels of acid suppression with esomeprazole
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