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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
330
Research Site
Tucson, Arizona, United States
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.
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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
...and 17 more locations