Acid-Associated Heartburn Symptoms and Dose of Esomeprazole

AstraZeneca

Status and phase

Completed

Phase 4

Conditions

Heartburn

Treatments

Drug: Esomeprazole magnesium (Nexium)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00206024

D9612L00064

Details and patient eligibility

About

This is a multi-center, double-blind, parallel-group, randomized, proof of concept trial to investigate the relationship between dose of esomeprazole magnesium and acid-associated heartburn symptoms during 4 weeks of treatment. The safety and tolerability of esomeprazole magnesium in doses up to 40 mg BID will also be assessed.

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Males and non-lactating females, aged 18 to 75 years, inclusive, with the ability to understand English and provide written informed consent
A history of heartburn for at least 6 months
A history of prior positive relief of heartburn symptoms from antacids or acid suppressive therapy
A positive esophageal acid perfusion test
At least 3 days of 'moderate' severity heartburn over the previous 7 days
No use of any acid suppression therapy (PPI, H2RA, etc.) within 14 days of randomization

Exclusion criteria

A history of gastric or esophageal surgery
H. pylori positive
A history of endoscopy -verified erosive esophagitis within the 16 weeks prior to randomization
Currently taking higher than the standard approved proton pump inhibitor doses
Historical evidence of a number of other GI, cardiovascular, pulmonary, liver, kidney, pancreatic, cerebral vascular diseases, organ transplant, or a condition requiring surgery.