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

NCT ID: NCT01286194

Last Updated: 2011-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-04-30

Study Completion Date

2007-01-31

Brief Summary

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

Detailed Description

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Conditions

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Frequent Heartburn

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Experimental 1

Rabeprazole sodium

Intervention Type DRUG

Rabeprazole sodium 10 mg orally every day for 14 days

Interventions

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Rabeprazole sodium

Rabeprazole sodium 10 mg orally every day for 14 days

Intervention Type DRUG

Eligibility Criteria

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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

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eisai Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Eisai, Inc

Principal Investigators

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Marco Cyrille, MD

Role: STUDY_DIRECTOR

Eisai Inc.

Locations

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Civic Center Pharmacy

Scottsdale, Arizona, United States

Site Status

Wynn's Pharmacy, Inc.

Griffin, Georgia, United States

Site Status

Monfort Drug Company, Inc.

Lawrenceville, Georgia, United States

Site Status

Eckerd Drug #234

Marietta, Georgia, United States

Site Status

The Medicine Shoppe

Kansas Ciry, Kansas, United States

Site Status

Stark Pharmacy

Overland Park, Kansas, United States

Site Status

Goodrich Pharmacy

Andover, Minnesota, United States

Site Status

Goodrich Pharmacy

Anoka, Minnesota, United States

Site Status

Goodrich Pharmacy

Blaine, Minnesota, United States

Site Status

Goodrich Pharmacy

Elk River, Minnesota, United States

Site Status

Goodrich Pharmacy

Saint Francis, Minnesota, United States

Site Status

North Oak Pharmacy

Kansas City, Missouri, United States

Site Status

Stevenson Family Pharmacy

Saint Joseph, Missouri, United States

Site Status

Countryside Pharmacy

Savannah, Missouri, United States

Site Status

Family Prescription Center

Bethlehem, Pennsylvania, United States

Site Status

T.B. Bond Pharmacy

Hillsboro, Texas, United States

Site Status

Studewood Pharmacy

Houston, Texas, United States

Site Status

Kashmere Pharmacy

Houston, Texas, United States

Site Status

Longhorn Drug Company

Kilgore, Texas, United States

Site Status

Louis Morgan Drug #1

Longview, Texas, United States

Site Status

The Medicine Shoppe #1511

Spring, Texas, United States

Site Status

West Houston Pharmacy

Tyler, Texas, United States

Site Status

Mountain View Pharmacy

Bountiful, Utah, United States

Site Status

Gibson United Drug

Murray, Utah, United States

Site Status

Apothecary Shoppe

Salt Lake Ciry, Utah, United States

Site Status

Jolley's Corner Pharmacy #1

Salt Lake City, Utah, United States

Site Status

Family Plaza Pharmacy

West Jordan, Utah, United States

Site Status

Montpelier Pharmacy, Inc.

Montpelier, Virginia, United States

Site Status

Lafayette Pharmacy

Richmond, Virginia, United States

Site Status

Rxtracare/U & I Pharmacy

Bellevue, Washington, United States

Site Status

Ostrom Drugs

Kenmore, Washington, United States

Site Status

Manhattan Drug

Seattle, Washington, United States

Site Status

Kusler's Pharmacy

Snohomish, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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E3810-A001-315

Identifier Type: -

Identifier Source: org_study_id