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

Frequent Heartburn Clinical Trial

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 of Heartburn Symptoms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01286194
• Other study ID #: E3810-A001-315
• Status: Completed
• Phase: Phase 4
• First received: January 11, 2011
• Last updated: January 28, 2011
• Start date: April 2006
• Est. completion date: January 2007

Study information

• Verified date: January 2006
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1500
• Est. completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Frequent Heartburn
• Heartburn

Intervention

Drug:
• Rabeprazole sodium
Rabeprazole sodium 10 mg orally every day for 14 days

Locations

Country	Name	City	State
United States	Goodrich Pharmacy	Andover	Minnesota
United States	Goodrich Pharmacy	Anoka	Minnesota
United States	Rxtracare/U & I Pharmacy	Bellevue	Washington
United States	Family Prescription Center	Bethlehem	Pennsylvania
United States	Goodrich Pharmacy	Blaine	Minnesota
United States	Mountain View Pharmacy	Bountiful	Utah
United States	Goodrich Pharmacy	Elk River	Minnesota
United States	Wynn's Pharmacy, Inc.	Griffin	Georgia
United States	T.B. Bond Pharmacy	Hillsboro	Texas
United States	Kashmere Pharmacy	Houston	Texas
United States	Studewood Pharmacy	Houston	Texas
United States	The Medicine Shoppe	Kansas Ciry	Kansas
United States	North Oak Pharmacy	Kansas City	Missouri
United States	Ostrom Drugs	Kenmore	Washington
United States	Longhorn Drug Company	Kilgore	Texas
United States	Monfort Drug Company, Inc.	Lawrenceville	Georgia
United States	Louis Morgan Drug #1	Longview	Texas
United States	Eckerd Drug #234	Marietta	Georgia
United States	Montpelier Pharmacy, Inc.	Montpelier	Virginia
United States	Gibson United Drug	Murray	Utah
United States	Stark Pharmacy	Overland Park	Kansas
United States	Lafayette Pharmacy	Richmond	Virginia
United States	Apothecary Shoppe	Salt Lake Ciry	Utah
United States	Jolley's Corner Pharmacy #1	Salt Lake City	Utah
United States	Countryside Pharmacy	Savannah	Missouri
United States	Civic Center Pharmacy	Scottsdale	Arizona
United States	Manhattan Drug	Seattle	Washington
United States	Kusler's Pharmacy	Snohomish	Washington
United States	The Medicine Shoppe #1511	Spring	Texas
United States	Stevenson Family Pharmacy	St Joseph	Missouri
United States	Goodrich Pharmacy	St. Francis	Minnesota
United States	West Houston Pharmacy	Tyler	Texas
United States	Family Plaza Pharmacy	West Jordan	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percentage of subjects who make an appropriate initial decision about whether to select AcipHex. OTC for their own use		screening visit (Day 0 )	No
Primary	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	No
Primary	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	No
Primary	The percentage of subjects who experience serious / non-serious adverse events		: 14 day treatment period; up to 4 months	Yes