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

Official Title: “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.

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.

Intervention(s) in this Clinical Trial

• 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: 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.

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: Placebo
  • Oral placebo tablet
• Experimental: Rabeprazole sodium 10 mg
  • oral rabeprazole 10 mg enteric-coated tablet

Primary Measures

• Complete Heartburn Relief During the First Full 24-Hour Period in the ITT Population.
  • Time Frame: first 24 hours
    Safety Issue?: No

Secondary Measures

• Summary of Percentage of Heartburn-free Daytimes, Intent-to-Treat (ITT) Population
  • Time Frame: 14-day treatment period.
    Safety Issue?: No
• Summary of Percentage of Heartburn-Free Nighttimes,Intent-to-Treat (ITT) Population
  • Time Frame: 14-day treatment period.
    Safety Issue?: No
• Change From Baseline in Average Regurgitation Severity Score Between Placebo and Rabeprazole.
  • Time Frame: 14-day treatment period.
    Safety Issue?: No
• Change From Baseline in Average Belching Severity Score Between Placebo and Rabeprazole.
  • Time Frame: 14-day treatment period.
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 19 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Eisai Inc. Industry

Overall Clinical Trial Officials and Contacts

Yufang Lu, MD, PhD Study Director Eisai Inc.  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00236184

Study ID Number: E3810-A001-313

ClinicalTrials.gov Identifier: NCT00236184

Health Authority: United States: Food and Drug Administration