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OpenTrials
Completed

NCT Number: NCT01286194

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 is a multi-center, open-label, all-comers OTC actual use study in pharmacy sites where the principal investigator will be a pharmacist.

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Key information

Conditions

Frequent Heartburn

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Civic Center Pharmacy, Scottsdale, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RABEPRAZOLE SODIUM

Drug

Rabeprazole sodium 10 mg orally every day for 14 days

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Eisai Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2006
Study completion
2007
First posted
Jan 31, 2011
Registry last updated
Jan 31, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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