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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

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.
 
ClinicalTrials.gov Identifier: NCT01286194
Recruitment Status : Completed
First Posted : January 31, 2011
Last Update Posted : January 31, 2011
Sponsor:
Information provided by:
Eisai Inc.

Study Description
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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 Design
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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

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


Outcome Measures
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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 ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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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 ClinicalTrials.gov identifier (NCT number): NCT01286194


Locations
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Sponsors and Collaborators
Eisai Inc.
Investigators
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Study Director: Marco Cyrille, MD Eisai Inc.
More Information
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Responsible Party: Marco Cyrille, MD, Eisai, Inc
ClinicalTrials.gov Identifier: NCT01286194    
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:
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Heartburn
Signs and Symptoms, Digestive
Signs and Symptoms
Rabeprazole
Anti-Ulcer Agents
 Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action