HeartburnPhase 3NCT00236184
E3810-A001-313: Efficacy and Safety of 10 mg Rabeprazole for Treating Heartburn in Frequent Sufferers
A Phase 3 study testing rabeprazole sodium in people with Heartburn, run by Eisai Inc. at 1 site in United States.
Trial summary
The purpose of this study is to investigate the safety and efficacy of rabeprazole sodium 10 mg in treating frequent heartburn. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Heartburn
- What is being tested?
- rabeprazole sodium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 629 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to Jun 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients > 18 years of age.
- If female, not of childbearing potential by reason of surgery or menopause, or of childbearing potential, but using an approved method of contraception since the last menstrual period. Females of childbearing potential must have a negative serum pregnancy test before starting the study.
- Patients must report a history of heartburn at least two days per week over the past month.
Who cannot join
- History of erosive esophagitis verified by endoscopy.
- History of gastroesophageal reflux disease (GERD) diagnosed by a physician.
- Patients who have a history of Barrett's esophagus or esophageal stricture.
- Evidence of any medical condition that may interfere with the conduct of the study, the interpretation of study results, or the health of the patient during the study.
- Patients who require continuous use of proton pump inhibitors, histamine receptor (H2) blockers, or prokinetics. Prior intermittent use of these agents is permitted if they are discontinued at least three days prior to the run-in phase. The H2 blocker, cimetidine (Tagamet®), must be discontinued for at least seven days before the study drug is administered.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate the safety and efficacy of rabeprazole sodium 10 mg in treating frequent heartburn.
Read the detailed description
This is a multicenter, double-blind, randomized, placebo-controlled study to investigate the safety and efficacy of rabeprazole 10 mg in treating frequent heartburn. The study will last for up to five weeks and consists of the following three phases: a one to two week screening period that includes a one-week, single-blind, placebo run-in phase, a two week double-blind, randomized treatment phase, and a one week single-blind, placebo follow-up phase.
- Conditions
- Heartburn
- Being tested
- rabeprazole sodium, Placebo
- Medical subject headings
- Heartburn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rabeprazole sodiumDrug
Also called Aciphex
Following a one week single-blind, placebo run-in phase, patients will receive rabeprazole 10 mg orally, once daily, for 14 days during the double-blind, randomized treatment phase. This will be followed by a one week single-blind placebo follow-up phase.
PlaceboOther
Following a one week single-blind, placebo run-in phase, patients will receive placebo orally, once daily, for 14 days during the double-blind, randomized treatment phase. This will be followed by a one week single-blind placebo follow-up phase.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Oral placebo tablet Receives: Other: Placebo |
| Rabeprazole sodium 10 mg | Experimental | oral rabeprazole 10 mg enteric-coated tablet Receives: Drug: rabeprazole sodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Heartburn Relief During the First Full 24-Hour Period in the ITT Population.
Subject was considered "complete relief" if he/she did not heartburn during the nighttime of the first dose date and no heartburn during the daytime of 1 day after the first dose date. The difference in complete relief within the first 24 hours between treatment groups was tested using a continuity corrected chi-square test without adjustment baseline heartburn severity.
Measured: first 24 hours
Secondary outcomes (4)
Summary of Percentage of Heartburn-free Daytimes, Intent-to-Treat (ITT) Population
comparison between placebo and treatment will be analyzed using two-sample t-test.
Measured: 14-day treatment period.
Summary of Percentage of Heartburn-Free Nighttimes,Intent-to-Treat (ITT) Population
comparison between placebo and treatment will be analyzed using two-sample t-test.
Measured: 14-day treatment period.
Change From Baseline in Average Regurgitation Severity Score Between Placebo and Rabeprazole.
comparison between placebo and treatment will be analyzed using two-sample t-test.
Measured: 14-day treatment period.
Change From Baseline in Average Belching Severity Score Between Placebo and Rabeprazole.
comparison between placebo and treatment will be analyzed using two-sample t-test.
Measured: 14-day treatment period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2005 (estimated)
- Study startOct 2005
- Primary completionMar 2006
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 629 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Yufang Lu, MD, PhD, Study director, Eisai Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00236184
- Sponsor's protocol ID
- E3810-A001-313
- Status last verified
- Mar 2010
- First submitted
- 10 Oct 2005
- Last updated
- 6 Apr 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- E3810-A001-313: Efficacy and Safety of 10 mg Rabeprazole for Treating Heartburn in Frequent Sufferers
- ClinicalTrials.gov ID
- NCT00236184
- Acronym / sponsor ID
- E3810-A001-313
- Conditions
- Heartburn
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 629 participants (actual)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2005
- Primary completion
- Mar 2006 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 12 Oct 2005 (estimated)
- Results
- Posted 1 Oct 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to investigate the safety and efficacy of rabeprazole sodium 10 mg in treating frequent heartburn.
Detailed description
This is a multicenter, double-blind, randomized, placebo-controlled study to investigate the safety and efficacy of rabeprazole 10 mg in treating frequent heartburn. The study will last for up to five weeks and consists of the following three phases: a one to two week screening period that includes a one-week, single-blind, placebo run-in phase, a two week double-blind, randomized treatment phase, and a one week single-blind, placebo follow-up phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboOral placebo tablet |
| Rabeprazole sodium 10 mg | Experimental | Drug: rabeprazole sodiumoral rabeprazole 10 mg enteric-coated tablet |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female patients > 18 years of age.
- If female, not of childbearing potential by reason of surgery or menopause, or of childbearing potential, but using an approved method of contraception since the last menstrual period. Females of childbearing potential must have a negative serum pregnancy test before starting the study.
- Patients must report a history of heartburn at least two days per week over the past month.
Key exclusion criteria (5 listed)
- History of erosive esophagitis verified by endoscopy.
- History of gastroesophageal reflux disease (GERD) diagnosed by a physician.
- Patients who have a history of Barrett's esophagus or esophageal stricture.
- Evidence of any medical condition that may interfere with the conduct of the study, the interpretation of study results, or the health of the patient during the study.
- Patients who require continuous use of proton pump inhibitors, histamine receptor (H2) blockers, or prokinetics. Prior intermittent use of these agents is permitted if they are discontinued at least three days prior to the run-in phase. The H2 blocker, cimetidine (Tagamet®), must be discontinued for at least seven days before the study drug is administered.
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 sodiumAlso: AciphexFollowing a one week single-blind, placebo run-in phase, patients will receive rabeprazole 10 mg orally, once daily, for 14 days during the double-blind, randomized treatment phase. This will be followed by a one week single-blind placebo follow-up phase. | Drug | Rabeprazole sodium 10 mg |
| PlaceboFollowing a one week single-blind, placebo run-in phase, patients will receive placebo orally, once daily, for 14 days during the double-blind, randomized treatment phase. This will be followed by a one week single-blind placebo follow-up phase. | Other | Placebo |
Primary outcome
Complete Heartburn Relief During the First Full 24-Hour Period in the ITT Population.
Time frame: first 24 hours
Subject was considered "complete relief" if he/she did not heartburn during the nighttime of the first dose date and no heartburn during the daytime of 1 day after the first dose date. The difference in complete relief within the first 24 hours between treatment groups was tested using a continuity corrected chi-square test without adjustment baseline heartburn severity.
4 secondary outcomes
Summary of Percentage of Heartburn-free Daytimes, Intent-to-Treat (ITT) Population
Time frame: 14-day treatment period.
Summary of Percentage of Heartburn-Free Nighttimes,Intent-to-Treat (ITT) Population
Time frame: 14-day treatment period.
Change From Baseline in Average Regurgitation Severity Score Between Placebo and Rabeprazole.
Time frame: 14-day treatment period.
Change From Baseline in Average Belching Severity Score Between Placebo and Rabeprazole.
Time frame: 14-day treatment period.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Heartburn
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Symptomatic Non-erosive Gastroesophageal Reflux Disease
Active, not recruitingPhase 3
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Digestive System Disorder, Dyspepsia
RecruitingObservational study
A Study of the Safety of Vonoprazan Exposure in Pregnant Women and Their Offspring
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Enrolling by invitationObservational study
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Not yet recruiting
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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.
Yufang Lu, MD, PhD study director
Eisai Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing rabeprazole sodium in people with Heartburn, run by Eisai Inc. at 1 site 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 3 inclusion and 5 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 6 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Oct 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Complete Heartburn Relief During the First Full 24-Hour Period in the ITT Population. (time frame: first 24 hours). 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 6 Apr 2010.