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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
History of Changes
  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:

U.S. FDA Resources

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

  Show 33 Study Locations
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, Digestive
Signs and Symptoms
Rabeprazole
Enzyme Inhibitors
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013