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

Status: Completed

Conditions: Frequent Heartburn

Treatments: Drug: Rabeprazole sodium

Study type: Observational

Funder types: Industry

Identifiers

NCT01286194

E3810-A001-315

Details and patient eligibility

About

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

Enrollment: 1,500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

1,500 participants in 1 patient group

Experimental 1

Treatment:

Drug: Rabeprazole sodium