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

Eisai Inc.1,500 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

1,500

Conditions

Frequent Heartburn

Interventions

Rabeprazole sodiumDRUG

Rabeprazole sodium 10 mg orally every day for 14 days

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (33)

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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