The purpose of this study is to investigate the safety and efficacy of rabeprazole 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
619
Following a one week single-blind, placebo run-in phase, patients will receive rabeprazole 10 mg orally,placebo 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.
New York Center For Clinical Research
Lake Success, New York, United States
Complete Heartburn Relief During the First Full 24-Hour Period in Intent-to-Treat (ITT) Population
The difference in complete relief within the first 24 hours between treatment and placebo in ITT was tested using a continuity corrected chi-square test withput adjustment for baseline severity.
Time frame: First 24 hours
Summary of Percentage of Heartburn-Free Daytimes
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
Time frame: 14-day randomized treatment period
Change From Baseline in Average Regurgitation Severity Score Between Placebo and Rabeprazole
Time frame: 14 day randomized treatment period
Change From Baseline in Average Belching Severity Score Between Placebo and Rabeprazole
Time frame: 14 day randomized treatment period
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