Acid-Associated Heartburn Symptoms and Dose of Esomeprazole

• Status: Completed
• Trial end date: 2005-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Esomeprazole

Criteria

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.