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

Sponsor:	Eisai Inc.
Information provided by:	Eisai Inc.
ClinicalTrials.gov Identifier:	NCT00236184

Purpose

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

Condition	Intervention	Phase
Heartburn	Drug: rabeprazole sodium Other: Placebo	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	E3810-A001-313: Efficacy and Safety of 10 mg Rabeprazole for Treating Heartburn in Frequent Sufferers

Resource links provided by NLM:

MedlinePlus related topics: Heartburn

Drug Information available for: Rabeprazole sodium

U.S. FDA Resources

Further study details as provided by Eisai Inc.:

Primary Outcome Measures:

Complete Heartburn Relief During the First Full 24-Hour Period in the ITT Population. [ Time Frame: first 24 hours ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

Summary of Percentage of Heartburn-free Daytimes, Intent-to-Treat (ITT) Population [ Time Frame: 14-day treatment period. ] [ Designated as safety issue: No ]
comparison between placebo and treatment will be analyzed using two-sample t-test.
Summary of Percentage of Heartburn-Free Nighttimes,Intent-to-Treat (ITT) Population [ Time Frame: 14-day treatment period. ] [ Designated as safety issue: No ]
comparison between placebo and treatment will be analyzed using two-sample t-test.
Change From Baseline in Average Regurgitation Severity Score Between Placebo and Rabeprazole. [ Time Frame: 14-day treatment period. ] [ Designated as safety issue: No ]
comparison between placebo and treatment will be analyzed using two-sample t-test.
Change From Baseline in Average Belching Severity Score Between Placebo and Rabeprazole. [ Time Frame: 14-day treatment period. ] [ Designated as safety issue: No ]
comparison between placebo and treatment will be analyzed using two-sample t-test.

Enrollment:	629
Study Start Date:	October 2005
Study Completion Date:	June 2008
Primary Completion Date:	March 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Name: Aciphex

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.

Eligibility

Ages Eligible for Study:	19 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00236184

Locations

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

Sponsors and Collaborators

Eisai Inc.

Investigators

Study Director:

Yufang Lu, MD, PhD

Eisai Inc.

More Information

No publications provided

Responsible Party:	Yufang Lu, Study Director, Eisai Medical Research Inc.
ClinicalTrials.gov Identifier:	NCT00236184 History of Changes
Other Study ID Numbers:	E3810-A001-313
Study First Received:	October 10, 2005
Results First Received:	August 26, 2009
Last Updated:	March 30, 2010
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Heartburn
Signs and Symptoms, Digestive
Signs and Symptoms
Rabeprazole
Enzyme Inhibitors

Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012