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

This study has been completed.
Sponsor:
Information provided by:
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT01286194
First received: January 11, 2011
Last updated: January 28, 2011
Last verified: January 2006
  Purpose

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 Intervention Phase
Frequent Heartburn
Drug: Rabeprazole sodium
Phase 4

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • 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 ) ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • The percentage of subjects who experience serious / non-serious adverse events [ Time Frame: : 14 day treatment period; up to 4 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1500
Study Start Date: April 2006
Estimated Study Completion Date: January 2007
Groups/Cohorts Assigned Interventions
Experimental 1 Drug: Rabeprazole sodium
Rabeprazole sodium 10 mg orally every day for 14 days

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

community sample

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01286194

  Hide Study Locations
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.
Investigators
Study Director: Marco Cyrille, MD Eisai Inc.
  More Information

No publications provided

Responsible Party: Marco Cyrille, MD, Eisai, Inc
ClinicalTrials.gov Identifier: NCT01286194     History of Changes
Other Study ID Numbers: E3810-A001-315
Study First Received: January 11, 2011
Last Updated: January 28, 2011
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 21, 2014