Acid-Associated Heartburn Symptoms and Dose of Esomeprazole

Completed · Phase 4

Conditions studied: Heartburn

In brief

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.

Key facts

Study ID

NCT00206024

Run by

AstraZeneca

People needed

330

Starts

2004-11-01

Expected to finish

2005-07-01

Last updated by the study team

2010-11-19

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Research Site — Tucson, Arizona, United States
• Research Site — Anaheim, California, United States
• Research Site — Orange, California, United States
• Research Site — San Diego, California, United States
• Research Site — Washington D.C., District of Columbia, United States
• Research Site — DeLand, Florida, United States
• Research Site — Miami, Florida, United States
• Research Site — New Smyrna Beach, Florida, United States
• Research Site — Tampa, Florida, United States
• Research Site — Zephyrhills, Florida, United States
• Research Site — Atlanta, Georgia, United States
• Research Site — Chicago, Illinois, United States
• Research Site — New Orleans, Louisiana, United States
• Research Site — Annapolis, Maryland, United States
• Research Site — Baltimore, Maryland, United States
• Research Site — Hollywood, Maryland, United States
• Research Site — Attleboro, Massachusetts, United States
• Research Site — Hackensack, New Jersey, United States
• Research Site — Vineland, New Jersey, United States
• Research Site — Rochester, New York, United States
• Research Site — Asheville, North Carolina, United States
• Research Site — Elkin, North Carolina, United States
• Research Site — Guthrie, Oklahoma, United States
• Research Site — Philadelphia, Pennsylvania, United States
• Research Site — Knoxville, Tennessee, United States

Full record on ClinicalTrials.gov

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