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:
Eisai Inc.
Information provided by:
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT01286194
First received: January 11, 2011
Last updated: January 28, 2011
Last verified: January 2006
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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 (Adult, Senior) |
| 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
Show 33 Study 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
| 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 Anti-Ulcer Agents |
Gastrointestinal Agents Proton Pump Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on September 23, 2016