The purpose of this study is to investigate the safety and efficacy of rabeprazole sodium 10 mg in treating frequent heartburn.
This is a multicenter, double-blind, randomized, placebo-controlled study to investigate the safety and efficacy of rabeprazole 10 mg in treating frequent heartburn. The study will last for up to five weeks and consists of the following three phases: a one to two week screening period that includes a one-week, single-blind, placebo run-in phase, a two week double-blind, randomized treatment phase, and a one week single-blind, placebo follow-up phase.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
629
Following a one week single-blind, placebo run-in phase, patients will receive rabeprazole 10 mg orally, once daily, for 14 days during the double-blind, randomized treatment phase. This will be followed by a one week single-blind placebo follow-up phase.
Following a one week single-blind, placebo run-in phase, patients will receive placebo orally, once daily, for 14 days during the double-blind, randomized treatment phase. This will be followed by a one week single-blind placebo follow-up phase.
Jeffrey L. Newman
Vista, California, United States
Complete Heartburn Relief During the First Full 24-Hour Period in the ITT Population.
Subject was considered "complete relief" if he/she did not heartburn during the nighttime of the first dose date and no heartburn during the daytime of 1 day after the first dose date. The difference in complete relief within the first 24 hours between treatment groups was tested using a continuity corrected chi-square test without adjustment baseline heartburn severity.
Time frame: first 24 hours
Summary of Percentage of Heartburn-free Daytimes, Intent-to-Treat (ITT) Population
comparison between placebo and treatment will be analyzed using two-sample t-test.
Time frame: 14-day treatment period.
Summary of Percentage of Heartburn-Free Nighttimes,Intent-to-Treat (ITT) Population
comparison between placebo and treatment will be analyzed using two-sample t-test.
Time frame: 14-day treatment period.
Change From Baseline in Average Regurgitation Severity Score Between Placebo and Rabeprazole.
comparison between placebo and treatment will be analyzed using two-sample t-test.
Time frame: 14-day treatment period.
Change From Baseline in Average Belching Severity Score Between Placebo and Rabeprazole.
comparison between placebo and treatment will be analyzed using two-sample t-test.
Time frame: 14-day treatment period.
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