The purpose of this study to determine the efficacy of 20 mg of rabeprazole given as a maintenance intermittent therapy following acute treatment for Symptomatic Gastroesophageal Reflux Disease (s-GERD).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
200
rabeprazole sodium tablet 20 mg once daily
Quality Care Medical Center Inc.
Vista, California, United States
The Percentage of Heartburn-free Days (24-hour Periods) During the 6-month Maintenance Treatment Phase (ITT Population).
The percentage of heartburn-free days during the 6-month Maintenance Treatment Phase in patients treated with rabeprazole 20 mg compared to patients who received placebo in the ITT Population. Heartburn-free day was defined as no heartburn in both the daytime and nighttime period on a given day. Note a total 388 subjects were enrolled at the beginning of Acute Phase and 200 subjects were enrolled into the double-blind 6-month maintenance treatment phase.
Time frame: 6 months double-blind maintenance phase
The Percent of Heartburn-free Daytime Period During the 6-month Maintenance Treatment Phase
The percentage of heartburn-free daytime period is presented cumulatively including all data collected during the 6-month Maintenance Phase
Time frame: 6-month maintenance phase
The Percent of Heartburn-free Nighttime Period During the 6-month Maintenance Treatment Phase
The percentage of heartburn-free nighttime period is presented cumulatively including all data collected during the 6-month
Time frame: 6-month maintenance phase
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