E3810-A001-313: 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 sodium 10 mg in treating frequent heartburn.

Study Overview

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

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): 629
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Vista, California, United States, 92084
      • Jeffrey L. Newman

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

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo; Oral placebo tablet	Other: 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.
EXPERIMENTAL: Rabeprazole sodium 10 mg; oral rabeprazole 10 mg enteric-coated tablet	Drug: 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.; Other Names: Aciphex

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 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.

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): April 6, 2010
• Last Update Submitted That Met QC Criteria: March 30, 2010
• Last Verified: March 1, 2010

More Information

Terms related to this study

• 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-A001-313