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

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT00243724

Collaborator

(none)

350

Enrollment

Locations

Duration (Months)

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

Anticipated 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 :

Apr 1, 2005

Actual Primary Completion Date :

Jun 1, 2007

Actual Study Completion Date :

Jun 1, 2007

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country
1	Research Site	Vancouver	British Columbia	Canada
2	Research Site	Halifax	Nova Scotia	Canada
3	Research Site	Guelph	Ontario	Canada
4	Research Site	Hamilton	Ontario	Canada
5	Research Site	Kingston	Ontario	Canada
6	Research Site	Mississauga	Ontario	Canada
7	Research Site	North York	Ontario	Canada
8	Research Site	Montreal	Quebec	Canada
9	Research Site	Pointe-Claire	Quebec	Canada
10	Research Site	Quebec		Canada