Frequent HeartburnNCT01286194
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
An observational study of Frequent Heartburn, run by Eisai Inc. at 33 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Frequent Heartburn
- What is being tested?
- Rabeprazole sodium
- Type of treatment
- Pill or oral medicine
- How many people
- 1,500 participants
- Where
- 33 sitesUnited States
- Study dates
- Apr 2006to Jan 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: community sample
Who may be able to join
- 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:
Show all 12Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
33 sites in 1 country.
33 sites in 1 country
United States33 sites
Goodrich Pharmacy
Andover, Minnesota, 55304
Goodrich Pharmacy
Anoka, Minnesota, 55303
Rxtracare/U & I Pharmacy
Bellevue, Washington, 98007
Family Prescription Center
Bethlehem, Pennsylvania, 18015
Goodrich Pharmacy
Blaine, Minnesota, 5544955449
Mountain View Pharmacy
Bountiful, Utah, 84010
Goodrich Pharmacy
Elk River, Minnesota, 55330
Wynn's Pharmacy, Inc.
Griffin, Georgia, 30224
T.B. Bond Pharmacy
Hillsboro, Texas, 76645
Studewood Pharmacy
Houston, Texas, 77008
Kashmere Pharmacy
Houston, Texas, 77020
The Medicine Shoppe
Kansas Ciry, Kansas, 66103
North Oak Pharmacy
Kansas City, Missouri, 64116
Ostrom Drugs
Kenmore, Washington, 98028
Longhorn Drug Company
Kilgore, Texas, 75662
Monfort Drug Company, Inc.
Lawrenceville, Georgia, 30045
Louis Morgan Drug #1
Longview, Texas, 75602
Eckerd Drug #234
Marietta, Georgia, 30064
Montpelier Pharmacy, Inc.
Montpelier, Virginia, 23192
Gibson United Drug
Murray, Utah, 84107
Stark Pharmacy
Overland Park, Kansas, 66209
Lafayette Pharmacy
Richmond, Virginia, 23221
Goodrich Pharmacy
Saint Francis, Minnesota, 55070
Stevenson Family Pharmacy
Saint Joseph, Missouri, 64504
Apothecary Shoppe
Salt Lake Ciry, Utah, 84102
Jolley's Corner Pharmacy #1
Salt Lake City, Utah, 84105
Countryside Pharmacy
Savannah, Missouri, 64485
Civic Center Pharmacy
Scottsdale, Arizona, 85251
Manhattan Drug
Seattle, Washington, 98148
Kusler's Pharmacy
Snohomish, Washington, 98290
The Medicine Shoppe #1511
Spring, Texas, 77379
West Houston Pharmacy
Tyler, Texas, 75702
Family Plaza Pharmacy
West Jordan, Utah, 84088
About this study
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
This is a multi-center, open-label, all-comers OTC actual use study in pharmacy sites where the principal investigator will be a pharmacist.
- Conditions
- Frequent Heartburn
- Being tested
- Rabeprazole sodium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rabeprazole sodiumDrug
Rabeprazole sodium 10 mg orally every day for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Experimental 1 | Not described Receives: Drug: Rabeprazole sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of subjects who make an appropriate initial decision about whether to select AcipHex. OTC for their own use
Measured: 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)
Measured: 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)
Measured: 14 day treatment period; up to 4 months
The percentage of subjects who experience serious / non-serious adverse events
Measured: : 14 day treatment period; up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2011 (estimated)
- Study startApr 2006
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frequent HeartburnStudies of the same condition, open and under way.
- More trials run by Eisai Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Marco Cyrille, MD, Study director, Eisai Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01286194
- Sponsor's protocol ID
- E3810-A001-315
- Status last verified
- Jan 2006
- First submitted
- 11 Jan 2011
- Last updated
- 31 Jan 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01286194
- Acronym / sponsor ID
- E3810-A001-315
- Conditions
- Frequent Heartburn
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2006
- Study completion
- Jan 2007
- First posted
- 31 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multi-center, open-label, all-comers OTC actual use study in pharmacy sites where the principal investigator will be a pharmacist.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental 1 | – | Drug: Rabeprazole sodium |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- community sample
Key inclusion criteria (12 listed)
- 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:
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rabeprazole sodiumRabeprazole sodium 10 mg orally every day for 14 days | Drug | Experimental 1 |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2011.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marco Cyrille, MD study director
Eisai Inc.
33 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Frequent Heartburn, run by Eisai Inc. at 33 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2011.