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

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Heartburn; Dyspepsia; Gastroesophageal Reflux

Treatments: Drug: Esomeprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT00243724

D9612L00078

Details and patient eligibility

About

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.

Enrollment: 350 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)