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

Completed

• Conditions: Frequent Heartburn
• Interventions: Drug: Rabeprazole sodium

• 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

Study Timeline

• Status Verified: 2006-01
• Study Start: 2006-04
• Study Completion: 2007-01
• Study First Submitted: 2011-01-11
• Study First Submitted QC: 2011-01-28
• Last Update Submitted: 2011-01-28
• Study First Posted: 2011-01-31
• Last Update Posted: 2011-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

Not provided

Exclusion Criteria

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

Trial Locations

Locations (29)

Civic Center Pharmacy; 🇺🇸 Scottsdale, Arizona, United States

Wynn's Pharmacy, Inc.; 🇺🇸 Griffin, Georgia, United States

Monfort Drug Company, Inc.; 🇺🇸 Lawrenceville, Georgia, United States

Eckerd Drug #234; 🇺🇸 Marietta, Georgia, United States

The Medicine Shoppe; 🇺🇸 Kansas Ciry, Kansas, United States

Stark Pharmacy; 🇺🇸 Overland Park, Kansas, United States

Goodrich Pharmacy; 🇺🇸 St. Francis, Minnesota, United States

North Oak Pharmacy; 🇺🇸 Kansas City, Missouri, United States

Countryside Pharmacy; 🇺🇸 Savannah, Missouri, United States

Stevenson Family Pharmacy; 🇺🇸 St Joseph, Missouri, United States

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