Frequent Heartburn
Conditions
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.
Interventions
DRUGRabeprazole sodium
Rabeprazole sodium 10 mg orally every day for 14 days
Sponsors
Eisai Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed