HEARD (long term) study – Histology of the Esophagus in Acid-Related Disease

Study identifier:D9612L00078

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

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.

Medical condition

Gastroesophageal Reflux

Phase

Phase 3

Healthy volunteers

No

Study drug

Esomeprazole

Sex

All

Actual Enrollment

350

Study type

Interventional

Age

18 Years +

Date

Study Start Date: 01 Apr 2005
Primary Completion Date: 01 Jun 2007
Study Completion Date: 01 Jun 2007

Study design

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

Verification:

Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals

Sponsors

AstraZeneca Pharmaceuticals

Collaborators

-

Inclusion and exclusion criteria