Acid-Associated Heartburn Symptoms and Dose of Esomeprazole
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||A 4-week Study to Investigate the Relationship Between Resolution of Acid-Associated Heartburn Symptoms and Dose of Esomeprazole Magnesium|
- Sustained resolution of heartburn during the 4th week of treatment, defined as 7 consecutive days with a daily e-diary heartburn assessment of "None".
- Relief of heartburn during the 4th week of treatment
- Cumulative daily sustained resolution rate through 4 weeks of treatment
- Time to first day of the first 7-day period of sustained resolution of heartburn
- Time to the first day of the first 7-day period of relief of heartburn
- Percentage of subject-reported heartburn-free days through 4 weeks of treatment
- Percentage of subject-reported heartburn-free nights through the 4 weeks of treatment
- Safety and tolerability: adverse events, clinical laboratory tests, vital signs, physical examination.
|Study Start Date:||November 2004|
|Study Completion Date:||July 2005|
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|Study Director:||Nexium Medical Science Director, MD||AstraZeneca|