Clinical trial NCT01286194: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Frequent Heartburn
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2011-01-31
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: community sample

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


Eligibility criteria: 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

Primary outcomes:
measure: The percentage of subjects who make an appropriate initial decision about whether to select AcipHex. OTC for their own use
timeFrame: screening visit (Day 0 )
measure: 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)
timeFrame: 14 day treatment period; up to 4 months
measure: 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)
timeFrame: 14 day treatment period; up to 4 months
measure: The percentage of subjects who experience serious / non-serious adverse events
timeFrame: : 14 day treatment period; up to 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Civic Center Pharmacy
state: Arizona
city: Griffin
country: United States
facility: Wynn's Pharmacy, Inc.
state: Georgia
city: Lawrenceville
country: United States
facility: Monfort Drug Company, Inc.
state: Georgia
city: Marietta
country: United States
facility: Eckerd Drug #234
state: Georgia
city: Kansas Ciry
country: United States
facility: The Medicine Shoppe
state: Kansas
city: Overland Park
country: United States
facility: Stark Pharmacy
state: Kansas
city: Andover
country: United States
facility: Goodrich Pharmacy
state: Minnesota
city: Anoka
country: United States
facility: Goodrich Pharmacy
state: Minnesota
city: Blaine
country: United States
facility: Goodrich Pharmacy
state: Minnesota
city: Elk River
country: United States
facility: Goodrich Pharmacy
state: Minnesota
city: St. Francis
country: United States
facility: Goodrich Pharmacy
state: Minnesota
city: Kansas City
country: United States
facility: North Oak Pharmacy
state: Missouri
city: Savannah
country: United States
facility: Countryside Pharmacy
state: Missouri
city: St Joseph
country: United States
facility: Stevenson Family Pharmacy
state: Missouri
city: Bethlehem
country: United States
facility: Family Prescription Center
state: Pennsylvania
city: Hillsboro
country: United States
facility: T.B. Bond Pharmacy
state: Texas
city: Houston
country: United States
facility: Studewood Pharmacy
state: Texas
city: Houston
country: United States
facility: Kashmere Pharmacy
state: Texas
city: Kilgore
country: United States
facility: Longhorn Drug Company
state: Texas
city: Longview
country: United States
facility: Louis Morgan Drug #1
state: Texas
city: Spring
country: United States
facility: The Medicine Shoppe #1511
state: Texas
city: Tyler
country: United States
facility: West Houston Pharmacy
state: Texas
city: Bountiful
country: United States
facility: Mountain View Pharmacy
state: Utah
city: Murray
country: United States
facility: Gibson United Drug
state: Utah
city: Salt Lake Ciry
country: United States
facility: Apothecary Shoppe
state: Utah
city: Salt Lake City
country: United States
facility: Jolley's Corner Pharmacy #1
state: Utah
city: West Jordan
country: United States
facility: Family Plaza Pharmacy
state: Utah
city: Montpelier
country: United States
facility: Montpelier Pharmacy, Inc.
state: Virginia
city: Richmond
country: United States
facility: Lafayette Pharmacy
state: Virginia
city: Bellevue
country: United States
facility: Rxtracare/U & I Pharmacy
state: Washington
city: Kenmore
country: United States
facility: Ostrom Drugs
state: Washington
city: Seattle
country: United States
facility: Manhattan Drug
state: Washington
city: Snohomish
country: United States
facility: Kusler's Pharmacy
state: Washington
Study officials:
affiliation: Eisai Inc.
name: Marco Cyrille, MD
role: STUDY_DIRECTOR
References: