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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

629 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2008-06-30

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.

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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.

Conditions

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Heartburn

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Oral placebo tablet

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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.

Rabeprazole sodium 10 mg

oral rabeprazole 10 mg enteric-coated tablet

Group Type EXPERIMENTAL

rabeprazole sodium

Intervention Type DRUG

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.

Interventions

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rabeprazole sodium

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.

Intervention Type DRUG

Placebo

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.

Intervention Type OTHER

Other Intervention Names

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Aciphex

Eligibility Criteria

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Inclusion Criteria

1. Male or female patients \> 18 years of age.
2. 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.
3. Patients must report a history of heartburn at least two days per week over the past month.

Exclusion Criteria

1. History of erosive esophagitis verified by endoscopy.
2. History of gastroesophageal reflux disease (GERD) diagnosed by a physician.
3. Patients who have a history of Barrett's esophagus or esophageal stricture.
4. 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.
5. 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.

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No