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
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ClinicalTrials.gov Identifier: NCT01286194 |
Recruitment Status :
Completed
First Posted : January 31, 2011
Last Update Posted : January 31, 2011
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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 |

Group/Cohort | Intervention/treatment |
---|---|
Experimental 1 |
Drug: Rabeprazole sodium
Rabeprazole sodium 10 mg orally every day for 14 days |
- 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 ) ]
- 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 ]
- 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 ]
- The percentage of subjects who experience serious / non-serious adverse events [ Time Frame: : 14 day treatment period; up to 4 months ]

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, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

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

Study Director: | Marco Cyrille, MD | Eisai Inc. |
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 |
Heartburn Signs and Symptoms, Digestive Rabeprazole Anti-Ulcer Agents |
Gastrointestinal Agents Proton Pump Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |