E3810-A001-312: Efficacy and Safety of 10 mg Rabeprazole for Treating Heartburn in Frequent Sufferers

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

Study Overview

• Status: Completed
• Conditions: Heartburn
• Intervention / Treatment: Drug: rabeprazole sodium; Drug: placebo

Detailed Description

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
• Enrollment (Actual): 619
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • New York
    • Lake Success, New York, United States, 11042
      • New York Center for Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Key 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.

Key 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: rabeprazole sodium; 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.; Other Names: Aciphex
Placebo Comparator: 2	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	First 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Summary of Percentage of Heartburn-Free Daytimes	comparison between placebo and treatment will be analyzed using two-sample t-test.	14-day treatment period.
Summary of Percentage of Heartburn-Free Nighttimes		14-day randomized treatment period
Change From Baseline in Average Regurgitation Severity Score Between Placebo and Rabeprazole		14 day randomized treatment period
Change From Baseline in Average Belching Severity Score Between Placebo and Rabeprazole		14 day randomized treatment period

Collaborators and Investigators

• Sponsor: Eisai Inc.

Study record dates

Study Major Dates

• Study Start: October 1, 2005
• Primary Completion (Actual): March 1, 2006
• Study Completion (Actual): June 1, 2008

Study Registration Dates

• First Submitted: October 10, 2005
• First Submitted That Met QC Criteria: October 10, 2005
• First Posted (Estimate): October 12, 2005

Study Record Updates

• Last Update Posted (Estimate): November 11, 2009
• Last Update Submitted That Met QC Criteria: November 4, 2009
• Last Verified: November 1, 2009

More Information

Terms related to this study

• Keywords: Rabeprazole; Heartburn
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Heartburn; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Rabeprazole
• Other Study ID Numbers: E3810-A001-312