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
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
1 other identifier
observational
1,500
1 country
33
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2006
Shorter than P25 for all trials
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 11, 2011
CompletedFirst Posted
Study publicly available on registry
January 31, 2011
CompletedJanuary 31, 2011
January 1, 2006
January 11, 2011
January 28, 2011
Conditions
Outcome Measures
Primary Outcomes (4)
The percentage of subjects who make an appropriate initial decision about whether to select AcipHex. OTC for their own use
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)
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)
14 day treatment period; up to 4 months
The percentage of subjects who experience serious / non-serious adverse events
: 14 day treatment period; up to 4 months
Study Arms (1)
Experimental 1
Interventions
Eligibility Criteria
community sample
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eisai Inc.lead
Study Sites (33)
Civic Center Pharmacy
Scottsdale, Arizona, 85251, United States
Wynn's Pharmacy, Inc.
Griffin, Georgia, 30224, United States
Monfort Drug Company, Inc.
Lawrenceville, Georgia, 30045, United States
Eckerd Drug #234
Marietta, Georgia, 30064, United States
The Medicine Shoppe
Kansas Ciry, Kansas, 66103, United States
Stark Pharmacy
Overland Park, Kansas, 66209, United States
Goodrich Pharmacy
Andover, Minnesota, 55304, United States
Goodrich Pharmacy
Anoka, Minnesota, 55303, United States
Goodrich Pharmacy
Blaine, Minnesota, 5544955449, United States
Goodrich Pharmacy
Elk River, Minnesota, 55330, United States
Goodrich Pharmacy
Saint Francis, Minnesota, 55070, United States
North Oak Pharmacy
Kansas City, Missouri, 64116, United States
Stevenson Family Pharmacy
Saint Joseph, Missouri, 64504, United States
Countryside Pharmacy
Savannah, Missouri, 64485, United States
Family Prescription Center
Bethlehem, Pennsylvania, 18015, United States
T.B. Bond Pharmacy
Hillsboro, Texas, 76645, United States
Studewood Pharmacy
Houston, Texas, 77008, United States
Kashmere Pharmacy
Houston, Texas, 77020, United States
Longhorn Drug Company
Kilgore, Texas, 75662, United States
Louis Morgan Drug #1
Longview, Texas, 75602, United States
The Medicine Shoppe #1511
Spring, Texas, 77379, United States
West Houston Pharmacy
Tyler, Texas, 75702, United States
Mountain View Pharmacy
Bountiful, Utah, 84010, United States
Gibson United Drug
Murray, Utah, 84107, United States
Apothecary Shoppe
Salt Lake Ciry, Utah, 84102, United States
Jolley's Corner Pharmacy #1
Salt Lake City, Utah, 84105, United States
Family Plaza Pharmacy
West Jordan, Utah, 84088, United States
Montpelier Pharmacy, Inc.
Montpelier, Virginia, 23192, United States
Lafayette Pharmacy
Richmond, Virginia, 23221, United States
Rxtracare/U & I Pharmacy
Bellevue, Washington, 98007, United States
Ostrom Drugs
Kenmore, Washington, 98028, United States
Manhattan Drug
Seattle, Washington, 98148, United States
Kusler's Pharmacy
Snohomish, Washington, 98290, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Marco Cyrille, MD
Eisai Inc.
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
January 11, 2011
First Posted
January 31, 2011
Study Start
April 1, 2006
Study Completion
January 1, 2007
Last Updated
January 31, 2011
Record last verified: 2006-01