Healia Clinical Trials Information Database

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.

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.

Status: Completed (Phase 3). Started on October 1st, 2005.

Enrollment: 629 subjects

Study Type: Interventional

Study Design:

  • Allocation: Randomized
  • Endpoint Classification: Safety/Efficacy Study
  • Intervention Model: Parallel Assignment
  • Masking: Double Blind (Subject
  • Investigator)
  • Primary Purpose: Treatment

Conditions:

Interventions:

  • Drug: rabeprazole sodium (Aciphex)
  • Other: Placebo

Eligibility

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

Both

Mininum Age

19 Years

Maximum Age

N/A

Healthy Volunteers

No


Resources

Source: Eisai Inc.

Authority: United States: Food and Drug Administration

Locations

  • Jeffrey L. Newman
    Vista
    California
    92084
    United States

Officials

  • Yufang Lu, MD, PhD (Study Director, Eisai Inc.)

Sponsors

  • Eisai Inc. (Lead Sponsor)

References

None.

Links

None.


Date Verified
March 1st, 2010
First Received
March 30th, 2010
Last Changed
March 30th, 2010

Information obtained from ClinicalTrials.gov on June 09, 2011. Link to the current ClinicalTrials.gov record.


All data in the Healia Clinical Trials Information Database and content displayed by the Healia Clinical Trials Search Engine are licensed from the National Institutes of Health (National Library of Medicine), which collects and maintains the data.

The Healia Clinical Trials Search Engine searches the data set at clinicaltrials.gov, providing up-to-date information about current clinical trials. In the Healia Clinical Trials Database you can find information on new experimental drugs, medical devices, and other types of treatments for all types of diseases. Each clinical trial description includes information about the phase of the trial (phase I, phase II, or phase III), the trial’s methods, such as whether it is a randomized, placebo controlled, double blind study, and the status of the trial including whether or not the trial is currently enrolling new participants.


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