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

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.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00243724

Enrollment

350

Registered

2005-10-25

Start date

2005-04-30

Completion date

2007-06-30

Last updated

2009-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyspepsia, Gastroesophageal Reflux, Heartburn

Keywords

immunohistochemical, erosive esophagitis, Acid reflux disease

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.

Interventions

DRUGEsomeprazole

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
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

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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026