A Study to Investigate Use Patterns and Safety in Simulated Actual Over-the-counter (OTC) Use of Rabeprazole Sodium for the Treatment of Heartburn Symptoms

January 28, 2011 updated by: Eisai Inc.

A Multi-Center, Open-Label, All-Comers, Single Group Observational Study to Investigate Use Patterns and Safety in Simulated Actual Over-the-counter (OTC )Use of Rabeprazole Sodium for the Treatment of Heartburn Symptoms

This is a multi-center, open-label, all-comers OTC actual use study in pharmacy sites where the principal investigator will be a pharmacist.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85251
        • Civic Center Pharmacy
    • Georgia
      • Griffin, Georgia, United States, 30224
        • Wynn's Pharmacy, Inc.
      • Lawrenceville, Georgia, United States, 30045
        • Monfort Drug Company, Inc.
      • Marietta, Georgia, United States, 30064
        • Eckerd Drug #234
    • Kansas
      • Kansas Ciry, Kansas, United States, 66103
        • The Medicine Shoppe
      • Overland Park, Kansas, United States, 66209
        • Stark Pharmacy
    • Minnesota
      • Andover, Minnesota, United States, 55304
        • Goodrich Pharmacy
      • Anoka, Minnesota, United States, 55303
        • Goodrich Pharmacy
      • Blaine, Minnesota, United States, 5544955449
        • Goodrich Pharmacy
      • Elk River, Minnesota, United States, 55330
        • Goodrich Pharmacy
      • St. Francis, Minnesota, United States, 55070
        • Goodrich Pharmacy
    • Missouri
      • Kansas City, Missouri, United States, 64116
        • North Oak Pharmacy
      • Savannah, Missouri, United States, 64485
        • Countryside Pharmacy
      • St Joseph, Missouri, United States, 64504
        • Stevenson Family Pharmacy
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
        • Family Prescription Center
    • Texas
      • Hillsboro, Texas, United States, 76645
        • T.B. Bond Pharmacy
      • Houston, Texas, United States, 77008
        • Studewood Pharmacy
      • Houston, Texas, United States, 77020
        • Kashmere Pharmacy
      • Kilgore, Texas, United States, 75662
        • Longhorn Drug Company
      • Longview, Texas, United States, 75602
        • Louis Morgan Drug #1
      • Spring, Texas, United States, 77379
        • The Medicine Shoppe #1511
      • Tyler, Texas, United States, 75702
        • West Houston Pharmacy
    • Utah
      • Bountiful, Utah, United States, 84010
        • Mountain View Pharmacy
      • Murray, Utah, United States, 84107
        • Gibson United Drug
      • Salt Lake Ciry, Utah, United States, 84102
        • Apothecary Shoppe
      • Salt Lake City, Utah, United States, 84105
        • Jolley's Corner Pharmacy #1
      • West Jordan, Utah, United States, 84088
        • Family Plaza Pharmacy
    • Virginia
      • Montpelier, Virginia, United States, 23192
        • Montpelier Pharmacy, Inc.
      • Richmond, Virginia, United States, 23221
        • Lafayette Pharmacy
    • Washington
      • Bellevue, Washington, United States, 98007
        • Rxtracare/U & I Pharmacy
      • Kenmore, Washington, United States, 98028
        • Ostrom Drugs
      • Seattle, Washington, United States, 98148
        • Manhattan Drug
      • Snohomish, Washington, United States, 98290
        • Kusler's Pharmacy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

community sample

Description

INCLUSION CRITERIA

To be eligible for participation, consumers must:

  • Male or female, 18 years of age or older
  • Select and purchase the study medication for their own use
  • Be able to take part in periodic telephone interviews regarding their use of and experience with the medication
  • Give written informed consent for participation

EXCLUSION CRITERIA Consumers will be excluded from participation if they meet any of the following criteria:

  • Allergic to rabeprazole
  • Currently have trouble or pain swallowing food
  • Currently have vomiting with blood
  • Currently have bloody or black stool
  • Currently pregnant or breast-feeding
  • Participated in a study regarding a heartburn medication during the last 12 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Experimental 1
Drug: Rabeprazole sodium
Rabeprazole sodium 10 mg orally every day for 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The percentage of subjects who make an appropriate initial decision about whether to select AcipHex. OTC for their own use
Time Frame: screening visit (Day 0 )
screening visit (Day 0 )
The percentage of subjects who follow key directions for use (1 tablet per day, 14-day course of treatment, and no more than one course of treatment every 4 months)
Time Frame: 14 day treatment period; up to 4 months
14 day treatment period; up to 4 months
The percentage of subjects who make appropriate ongoing decisions about suitability for treatment (including consulting a physician and appropriately modifying or discontinuing use based on label directions)
Time Frame: 14 day treatment period; up to 4 months
14 day treatment period; up to 4 months
The percentage of subjects who experience serious / non-serious adverse events
Time Frame: : 14 day treatment period; up to 4 months
: 14 day treatment period; up to 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eisai Inc.

Investigators

  • Study Director: Marco Cyrille, MD, Eisai Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Study Completion

January 1, 2007

Study Registration Dates

First Submitted

January 11, 2011

First Submitted That Met QC Criteria

January 28, 2011

First Posted (Estimate)

January 31, 2011

Study Record Updates

Last Update Posted (Estimate)

January 31, 2011

Last Update Submitted That Met QC Criteria

January 28, 2011

Last Verified

January 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E3810-A001-315

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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