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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01286194
Recruitment Status : Completed
First Posted : January 31, 2011
Last Update Posted : January 31, 2011
Information provided by:
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.

Condition or disease Intervention/treatment
Frequent Heartburn Drug: Rabeprazole sodium

Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Study Start Date : April 2006
Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Experimental 1 Drug: Rabeprazole sodium
Rabeprazole sodium 10 mg orally every day for 14 days

Primary Outcome Measures :
  1. 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 ) ]
  2. 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 ]
  3. 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 ]
  4. The percentage of subjects who experience serious / non-serious adverse events [ Time Frame: : 14 day treatment period; up to 4 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
community sample


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01286194

  Hide Study Locations
United States, Arizona
Civic Center Pharmacy
Scottsdale, Arizona, United States, 85251
United States, Georgia
Wynn's Pharmacy, Inc.
Griffin, Georgia, United States, 30224
Monfort Drug Company, Inc.
Lawrenceville, Georgia, United States, 30045
Eckerd Drug #234
Marietta, Georgia, United States, 30064
United States, Kansas
The Medicine Shoppe
Kansas Ciry, Kansas, United States, 66103
Stark Pharmacy
Overland Park, Kansas, United States, 66209
United States, Minnesota
Goodrich Pharmacy
Andover, Minnesota, United States, 55304
Goodrich Pharmacy
Anoka, Minnesota, United States, 55303
Goodrich Pharmacy
Blaine, Minnesota, United States, 5544955449
Goodrich Pharmacy
Elk River, Minnesota, United States, 55330
Goodrich Pharmacy
St. Francis, Minnesota, United States, 55070
United States, Missouri
North Oak Pharmacy
Kansas City, Missouri, United States, 64116
Countryside Pharmacy
Savannah, Missouri, United States, 64485
Stevenson Family Pharmacy
St Joseph, Missouri, United States, 64504
United States, Pennsylvania
Family Prescription Center
Bethlehem, Pennsylvania, United States, 18015
United States, Texas
T.B. Bond Pharmacy
Hillsboro, Texas, United States, 76645
Studewood Pharmacy
Houston, Texas, United States, 77008
Kashmere Pharmacy
Houston, Texas, United States, 77020
Longhorn Drug Company
Kilgore, Texas, United States, 75662
Louis Morgan Drug #1
Longview, Texas, United States, 75602
The Medicine Shoppe #1511
Spring, Texas, United States, 77379
West Houston Pharmacy
Tyler, Texas, United States, 75702
United States, Utah
Mountain View Pharmacy
Bountiful, Utah, United States, 84010
Gibson United Drug
Murray, Utah, United States, 84107
Apothecary Shoppe
Salt Lake Ciry, Utah, United States, 84102
Jolley's Corner Pharmacy #1
Salt Lake City, Utah, United States, 84105
Family Plaza Pharmacy
West Jordan, Utah, United States, 84088
United States, Virginia
Montpelier Pharmacy, Inc.
Montpelier, Virginia, United States, 23192
Lafayette Pharmacy
Richmond, Virginia, United States, 23221
United States, Washington
Rxtracare/U & I Pharmacy
Bellevue, Washington, United States, 98007
Ostrom Drugs
Kenmore, Washington, United States, 98028
Manhattan Drug
Seattle, Washington, United States, 98148
Kusler's Pharmacy
Snohomish, Washington, United States, 98290
Sponsors and Collaborators
Eisai Inc.
Study Director: Marco Cyrille, MD Eisai Inc.

Responsible Party: Marco Cyrille, MD, Eisai, Inc Identifier: NCT01286194     History of Changes
Other Study ID Numbers: E3810-A001-315
First Posted: January 31, 2011    Key Record Dates
Last Update Posted: January 31, 2011
Last Verified: January 2006

Additional relevant MeSH terms:
Signs and Symptoms, Digestive
Signs and Symptoms
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action