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
- Registration Number
- NCT01286194
- Lead Sponsor
- Eisai Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1500
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Experimental 1 Rabeprazole sodium -
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (29)
Eckerd Drug #234
🇺🇸Marietta, Georgia, United States
The Medicine Shoppe
🇺🇸Kansas Ciry, Kansas, United States
Studewood Pharmacy
🇺🇸Houston, Texas, United States
Lafayette Pharmacy
🇺🇸Richmond, Virginia, United States
Manhattan Drug
🇺🇸Seattle, Washington, United States
Longhorn Drug Company
🇺🇸Kilgore, Texas, United States
Montpelier Pharmacy, Inc.
🇺🇸Montpelier, Virginia, United States
Stevenson Family Pharmacy
🇺🇸St Joseph, Missouri, United States
West Houston Pharmacy
🇺🇸Tyler, Texas, United States
Wynn's Pharmacy, Inc.
🇺🇸Griffin, Georgia, United States
Goodrich Pharmacy
🇺🇸St. Francis, Minnesota, United States
The Medicine Shoppe #1511
🇺🇸Spring, Texas, United States
Stark Pharmacy
🇺🇸Overland Park, Kansas, United States
Family Prescription Center
🇺🇸Bethlehem, Pennsylvania, United States
Kashmere Pharmacy
🇺🇸Houston, Texas, United States
Gibson United Drug
🇺🇸Murray, Utah, United States
Family Plaza Pharmacy
🇺🇸West Jordan, Utah, United States
Ostrom Drugs
🇺🇸Kenmore, Washington, United States
Monfort Drug Company, Inc.
🇺🇸Lawrenceville, Georgia, United States
Civic Center Pharmacy
🇺🇸Scottsdale, Arizona, United States
Countryside Pharmacy
🇺🇸Savannah, Missouri, United States
North Oak Pharmacy
🇺🇸Kansas City, Missouri, United States
Louis Morgan Drug #1
🇺🇸Longview, Texas, United States
T.B. Bond Pharmacy
🇺🇸Hillsboro, Texas, United States
Apothecary Shoppe
🇺🇸Salt Lake Ciry, Utah, United States
Kusler's Pharmacy
🇺🇸Snohomish, Washington, United States
Jolley's Corner Pharmacy #1
🇺🇸Salt Lake City, Utah, United States
Rxtracare/U & I Pharmacy
🇺🇸Bellevue, Washington, United States
Mountain View Pharmacy
🇺🇸Bountiful, Utah, United States