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

Phase 3

Completed

• Conditions: Heartburn
• Interventions: Drug: placebo; Drug: rabeprazole sodium

• Registration Number: NCT00236197
• Lead Sponsor: Eisai Inc.

Brief Summary

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

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 Timeline

• Study Start: 2005-10
• Study First Submitted: 2005-10-10
• Study First Submitted QC: 2005-10-10
• Study First Posted: 2005-10-12
• Primary Completion: 2006-03
• Study Completion: 2008-06
• Results First Submitted: 2009-08-25
• Status Verified: 2009-11
• Results First Submitted QC: 2009-11-03
• Last Update Submitted: 2009-11-04
• Results First Posted: 2009-11-05
• Last Update Posted: 2009-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 619

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	placebo	-
1	rabeprazole sodium	-

Primary Outcome Measures

Name	Time	Method
Complete Heartburn Relief During the First Full 24-Hour Period in Intent-to-Treat (ITT) Population	First 24 hours	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.

Secondary Outcome Measures

Name	Time	Method
Summary of Percentage of Heartburn-Free Daytimes	14-day treatment period.	comparison between placebo and treatment will be analyzed using two-sample t-test.
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

Trial Locations

Locations (1)

New York Center For Clinical Research; 🇺🇸 Lake Success, New York, United States