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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental 1
Drug: Rabeprazole sodium
Rabeprazole sodium 10 mg orally every day for 14 days

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eisai Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2006

Study Completion

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2007

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 11, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 28, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 31, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 31, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 28, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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