E3810-A001-313: Efficacy and Safety of 10 mg Rabeprazole for Treating Heartburn in Frequent Sufferers

Study Overview
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Brief Summary
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The purpose of this study is to investigate the safety and efficacy of rabeprazole sodium 10 mg in treating frequent heartburn.

Detailed Description
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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.

Official Title
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E3810-A001-313: Efficacy and Safety of 10 mg Rabeprazole for Treating Heartburn in Frequent Sufferers

Conditions
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Heartburn

Intervention / Treatment
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* Drug: rabeprazole sodium
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female patients > 18 years of age. If female, not of childbearing potential by reason of surgery or menopause, or of childbearing potential, but using an approved method of contraception since the last menstrual period. Females of childbearing potential must have a negative serum pregnancy test before starting the study. Patients must report a history of heartburn at least two days per week over the past month. Exclusion Criteria: History of erosive esophagitis verified by endoscopy. History of gastroesophageal reflux disease (GERD) diagnosed by a physician. Patients who have a history of Barrett's esophagus or esophageal stricture. Evidence of any medical condition that may interfere with the conduct of the study, the interpretation of study results, or the health of the patient during the study. Patients who require continuous use of proton pump inhibitors, histamine receptor (H2) blockers, or prokinetics. Prior intermittent use of these agents is permitted if they are discontinued at least three days prior to the run-in phase. The H2 blocker, cimetidine (Tagamet®), must be discontinued for at least seven days before the study drug is administered.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Oral placebo tablet | Other: Placebo<br>* 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.<br>|
| Experimental: Rabeprazole sodium 10 mg<br>oral rabeprazole 10 mg enteric-coated tablet | Drug: rabeprazole sodium<br>* 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.<br>* Other names: Aciphex;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | first 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 14-day treatment period. |