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

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

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

Study Primary Completion Date: March 2006

Intervention(s) in this Clinical Trial

• Drug: Rabeprazole sodium

Primary Measures

• All efficacy assessments will be derived from data recorded in the patients' daily diaries. Patients will record the incidence and severity of their heartburn, symptoms of regurgitation, belching, bloating and antacid consumption.
  • Safety Issue?: No

Secondary Measures

• Adverse event monitoring will assess safety.
  • Safety Issue?: Yes

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.
• Heartburn must have responded in the past to some degree to antacids or over the counter H2 receptor antagonist treatment.
• Patients need to be able to provide written informed consent and able and willing to complete a daily diary and return for all study visits.

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.
• Females who are pregnant or lactating.
• Patients with a known or suspected history of alcohol or drug misuse within five years.
• Patients who have participated in another investigational drug study within 30 days prior to screening or are expected to receive an investigational drug during this trial.
• Patients with a history of allergy or sensitivity to proton pump inhibitors and/or
• Gelusil® or to their inactive ingredients.
• Patients with malignancy or treatment for malignancy within the year prior to study entry, except simple excision of basal cell carcinoma.
• Patients with clinically relevant abnormal laboratory tests at the initial visit.
• Patients who require continuous use of PPIs, 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.
• Patients who are receiving warfarin.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 19 Years

Maximum Age for this Clinical Trial: N/A

Lead Sponsor: Eisai Medical Research Inc.

Overall Clinical Trial Officials and Contacts

Claudio Pasquinelli Study Director Eisai Medical Research Inc.  

Information obtained from ClinicalTrials.gov on September 05, 2008

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