Status:
COMPLETED
Acid-Associated Heartburn Symptoms and Dose of Esomeprazole
Lead Sponsor:
AstraZeneca
Conditions:
Heartburn
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief 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 d...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
End Date :
July 1 2005
Estimated Enrollment :
330 Patients enrolled
Trial Details
Trial ID
NCT00206024
Start Date
November 1 2004
End Date
July 1 2005
Last Update
November 19 2010
Active Locations (27)
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1
Research Site
Tucson, Arizona, United States
2
Research Site
Anaheim, California, United States
3
Research Site
Orange, California, United States
4
Research Site
San Diego, California, United States