Clinical Trial: 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
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
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 o
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 Summary:
Sponsor: Eisai Inc.
Current Primary Outcome:
- 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 ) ]
- 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 ]
- 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 ]
- The percentage of subjects who experience serious / non-serious adverse events [ Time Frame: : 14 day treatment period; up to 4 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Eisai Inc.
Dates:
Date Received: January 11, 2011
Date Started: April 2006
Date Completion: January 2007
Last Updated: January 28, 2011
Last Verified: January 2006