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

Phase 3

Completed

• Conditions: Gastroesophageal Reflux; Heartburn; Dyspepsia

• Registration Number: NCT00243724
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-04
• Study First Submitted: 2005-10-24
• Study First Submitted QC: 2005-10-24
• Study First Posted: 2005-10-25
• Primary Completion: 2007-06
• Study Completion: 2007-06
• Status Verified: 2009-03
• Last Update Submitted: 2009-03-25
• Last Update Posted: 2009-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 350

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Changes in immunohistochemical markers of esophageal epithelial acid-related disease after 6 months treatment with different levels of acid suppression with esomeprazole

Trial Locations

Locations (1)

Research Site; 🇨🇦 Quebec, Canada