Official Title: “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 Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Safety Study

Study Primary Completion Date: March 2006

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 or 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.
• Drug: Placebo
  • Following a one week single-blind, placebo run-in phase, patients will receive placebo or 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.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Placebo Comparator: 2

Primary Measures

• The difference in complete relief within the first 24 hours between treatment and placebo will be tested using a continuity corrected chi-square test. The primary analysis will be on the intent-to-treat population.
  • Time Frame: First 24 hours between treatment and placebo.
    Safety Issue?: No
• Assessments will be derived from patients' daily diaries.
  • Time Frame: First 24 hours between treatment and placebo.
    Safety Issue?: No

Secondary Measures

• Heartburn-free daytimes and nighttimes, and the change from baseline in average regurgitation scores and in average belching scores between rabeprazole and placebo will be evaluated.
  • Time Frame: 14-day treatment period.
    Safety Issue?: No
• Change will be analyzed using two-sample t-test. Data will be derived from patients' daily diaries.
  • Time Frame: 14-day treatment period.
    Safety Issue?: No
• Tertiary Outcome: the change from baseline in average bloating scores and in the average daily antacid consumption, between treatment and placebo will be evaluated.
  • Time Frame: 14-day treatment period.
    Safety Issue?: Yes
• Tertiary Outcome: change will be analyzed using two-sample t-test. Data will be derived from patients' daily diaries. Adverse event monitoring will assess safety. Safety outcomes will be displayed by descriptive statistics.
  • Time Frame: 14-day treatment period.
    Safety Issue?: Yes

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.

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 Sponsor: Eisai Medical Research Inc.

Overall Clinical Trial Officials and Contacts

Yufang Lu Study Director Eisai Medical Research Inc.  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00236197

Study ID Number: E3810-A001-312

ClinicalTrials.gov Identifier: NCT00236197

Health Authority: United States: Food and Drug Administration