This study will investigate the efficacy of esomeprazole 20 mg once a day in the treatment of frequent heartburn
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
340
Nexium 20 mg administered as 22.3 mg of esomeprasole magnesium hydrate, capsule, oral dose
Research site
Sacramento, California, United States
Research site
Seminole, Florida, United States
Research site
Meridian, Idaho, United States
Research site
Indianapolis, Indiana, United States
Percentage of Heartburn Free 24 Hour Days During 14 Days of Randomized Treatment
Time frame: From randomisation to day 14
Percentage of Heartburn Free 24 Hour Days During 14 Days of Randomized Treatment
Time frame: From randomization to day 14
Number of Subjects Reporting Heartburn 2 Days or Less During the 14 Days Randomized Treatment Period
Randomized treatment period is considered as both weeks 1 and 2 between V3 and V4.
Time frame: From randomisation to day 14
Comparison of Number of Subjects With 0, 1, 2, 3 or 4 Days With no Heartburn Over Days 1 to 4 Between Esomeprazole 20 mg and Placebo
The first 4 consecutive days subjects were on randomized treatment, between V3 and V4.
Time frame: From randomisation to the day 14
Number of Subjects With Heartburn 1 Day or Less During the Final Week, Second Week, First Week of Treatment
There were three separate 7 day time periods during the treatment period; The first week (days 1-7), the second week (days 8-14), and the last 7 consecutive days (last day subject reported and the prior 6). For a given subject, the second week and last 7 consecutive days are the same if the subject has recorded measurements for the entire 14 day treatment period. However, for subjects reporting anything less than 14 days the two will not be identical. For all three 7 day time periods, days when a subject did not call in (i.e., missing values) were imputed as a day with heartburn.
Time frame: From randomisation to day 14
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Research site
Metairie, Louisiana, United States
Research site
Omaha, Nebraska, United States
Research site
Raleigh, North Carolina, United States
Research site
Cleveland, Ohio, United States
Research site
Mt. Pleasant, South Carolina, United States
Research site
San Antonio, Texas, United States