Gastroesophageal RefluxPhase 3NCT00553449
Open Label Study Evaluating Different Dosing Regimens of Rabeprazole in Gastro-esophageal Reflux Disease (GERD) Patients With Night-time Heartburn Symptoms.
A Phase 3 study testing rabeprazole in people with Gastroesophageal Reflux and Heartburn, run by Janssen-Ortho Inc., Canada.
Trial summary
The purpose of this study is to evaluate the effect of each of the rabeprazole treatment regimens on nocturnal heartburn symptoms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroesophageal Reflux, Heartburn
- What is being tested?
- rabeprazole
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- Jul 2004to Sep 2005
- Phase
- Phase 3
- 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
Who may be able to join
- Patients must have had a minimum three-month history of symptomatic GERD, with heartburn as the predominant symptom, and must report nocturnal heartburn symptoms (i.e., heartburn symptoms experienced during the night-time period, between 2200 and 0600h)
- Patients must currently be taking a proton-pump inhibitor (PPI) or histamine-2 receptor antagonist (H2RA) at least four weeks prior to study admission
- Patients must be able to read, write and understand the language of the HRQOL and productivity assessment instruments (PAGI-SYM, PAGI-QOL, WPAI-GH) i.e., English or French
- Patients must have been at least 80% compliant with their current acid suppressive therapy, and must have completed a minimum of 11 of 14 nocturnal heartburn ratings during the run-in period (i.e. <=3 "missing" nocturnal heartburn ratings during the 14-day period)
- Patients must have a total nocturnal heartburn symptom score of >4 points during the 2-week run-in period
- 3 "missing" nocturnal heartburn ratings during the 14-day period) as recorded in the diary
- Night-time heartburn control assessment of "very dissatisfied, dissatisfied, neither dissatisfied nor satisfied" at the end of the 2-week run-in period.
Who cannot join
- Patients currently taking rabeprazole 20mg once daily (morning or evening administration) or 10mg twice daily (morning and evening administration) on a continuous basis
- Documented evidence of GERD refractory to acid suppressive therapy (i.e.
- no or poor clinical response to at least two treatment courses of 4-weeks duration with a PPI)
- Esophagitis known to be the result of systemic events (e.g. scleroderma, ingested irritants)
- Active GI bleeding, or presence of "alarm symptoms" (i.e., vomiting, blood in stool, anemia, dysphagia)
- Documented history of significant pyloric stenosis or esophageal ring stricture
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- Documented evidence of esophageal or gastric varices
- Patients with primary motility disorders, infectious or inflammatory conditions of the small or large intestine, malabsorption syndromes, GI obstruction, history of gastrointestinal malignancy, definitive acid-lowering surgery or other esophageal, gastric or intestinal surgery (including vagotomy) except for simple closure of perforation
- Patients who are unable or unwilling to discontinue the use of prostaglandins (e.g. misoprostol), sucralfate, prokinetic agents (e.g. metoclopramide), anticholinergics, cholinergic agents or spasmolytics. Use of opiates may be continued if started at least 2 weeks before study admission and the dosage is consistent (± 25% for total opioid daily dose) throughout the study
- Treatment with high-dose systemic corticosteroids (>10mg/day prednisone equivalent) and NSAIDs, including COX-2 selective inhibitors, cannot be initiated at anytime during the study. However, patients taking corticosteroids and NSAIDs (including ASA) before study entry may continue these medications during the study, however, they must have been taking a stable dose (e.g. for oral medication, a consistent daily dose ± 25%) for at least 2 weeks before study admission and the dosage must be kept constant throughout the study. Occasional, intermittent use of NSAIDs for acute, self-limiting conditions (e.g. headache relief) is acceptable during the study
- >3 daytime episodes during any 7 consecutive days of the run-in period
- >1 severe or very severe daytime episode (i.e., more than 1 daytime heartburn episode rated >=3) during any 7 consecutive days of the run-in period
- Maximum total daytime heartburn score >5 during any 7 consecutive days of the run-in period.
About this study
Official title: A Randomised, Controlled, Parallel-group, Open-label Study to Evaluate Different Dosing Regimens of Rabeprazole in Controlling Nocturnal Heartburn Symptoms in Patients With Gastroesophageal Reflux Disease.
The purpose of this study is to evaluate the effect of each of the rabeprazole treatment regimens on nocturnal heartburn symptoms.
Read the detailed description
There is limited data regarding the estimate of patients who experience nocturnal symptoms despite adequate daytime heartburn control, the incidence and severity of nocturnal heartburn episodes after a minimum of 4 weeks of acid suppressive therapy with a Proton-pump inhibitor (PPI) or Histamine -2-receptor antagonist (H2RA), and the effect of instituting rabeprazole therapy after failure to control nocturnal heartburn symptoms with other acid suppressive therapy. This is a multicentre, randomised (study medication is assigned by chance), controlled, parallel-group, open-label study in GERD patients. Patients will be screened and enter a 2-week run-in phase to document heartburn symptoms while on their current therapy, during which they will complete a daily diary of symptoms and antacid use. Patients who have troublesome nocturnal heartburn episodes, but adequate daytime heartburn symptom control (as defined) will enter an 8-week treatment phase where they are randomised to one of the rabeprazole regimens: 20mg once daily in the evening (dose administered 30minutes prior to the evening meal; "QPM" regimen), 10mg twice daily (dose administered 30minutes prior to the morning and evening meals; "BID/twice daily" regimen) or 20mg once daily in the morning (dose administered 30minutes prior to the morning meal; "QAM/every morning" regimen), plus antacids as required. The study hypothesis is that after failure to control night-time heartburn symptoms with other acid suppressive therapy, instituting rabeprazole will have a beneficial effect. Safety assessments include: physical examination and pregnancy test at screening, vital signs and weight at randomization and final visit, adverse event and concomitant medication reporting at every visit. Rabeprazole 20mg once daily in the evening: one rabeprazole 20mg tablet daily in the evening, 30-60 minutes before dinner for 56 days OR Rabeprazole 10mg twice daily: one rabeprazole 10mg tablet in the morning, 30-60 minutes before breakfast, and one rabeprazole 10mg tablet 30-60 minutes before dinner for 56 days. OR Rabeprazole 20mg once daily in the morning: one rabeprazole 20mg tablet daily in the morning, 30-60 minutes before breakfast for 56 days.
- Conditions
- Gastroesophageal Reflux, Heartburn
- Being tested
- rabeprazole
- Keywords
- nocturnal heartburn, day-time heartburn, rabeprazole, GERD
- Medical subject headings
- Gastroesophageal Reflux, Heartburn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rabeprazoleDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary analysis will be based on the mean nocturnal heartburn score observed after four weeks of drug administration for each of the three dosing regimens of rabeprazole.
Secondary outcomes (1)
Nocturnal heartburn score at end of treatment/ 8 weeks; HRQoL and productivity outcomes 4 & 8 wks; rescue meds usage & compliance with study meds over entire study; day-time heartburn score 4 & 8 wks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2007 (estimated)
- Study startJul 2004
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal RefluxStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen-Ortho Inc., Canada
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Janssen-Ortho Inc. Clinical Trial, Study director, Janssen-Ortho Inc., Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00553449
- Sponsor's protocol ID
- CR005692
- Status last verified
- Mar 2010
- First submitted
- 1 Nov 2007
- Last updated
- 17 May 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Controlled, Parallel-group, Open-label Study to Evaluate Different Dosing Regimens of Rabeprazole in Controlling Nocturnal Heartburn Symptoms in Patients With Gastroesophageal Reflux Disease.
- ClinicalTrials.gov ID
- NCT00553449
- Acronym / sponsor ID
- CR005692
- Conditions
- Gastroesophageal Reflux, Heartburn
- Keywords
- nocturnal heartburn, day-time heartburn, rabeprazole, GERD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Janssen-Ortho Inc., CanadaIndustry (pharma, biotech, devices)
- Study start
- Jul 2004
- Study completion
- Sep 2005 (actual)
- First posted
- 5 Nov 2007 (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.
The purpose of this study is to evaluate the effect of each of the rabeprazole treatment regimens on nocturnal heartburn symptoms.
Detailed description
There is limited data regarding the estimate of patients who experience nocturnal symptoms despite adequate daytime heartburn control, the incidence and severity of nocturnal heartburn episodes after a minimum of 4 weeks of acid suppressive therapy with a Proton-pump inhibitor (PPI) or Histamine -2-receptor antagonist (H2RA), and the effect of instituting rabeprazole therapy after failure to control nocturnal heartburn symptoms with other acid suppressive therapy. This is a multicentre, randomised (study medication is assigned by chance), controlled, parallel-group, open-label study in GERD patients. Patients will be screened and enter a 2-week run-in phase to document heartburn symptoms while on their current therapy, during which they will complete a daily diary of symptoms and antacid use. Patients who have troublesome nocturnal heartburn episodes, but adequate daytime heartburn symptom control (as defined) will enter an 8-week treatment phase where they are randomised to one of the rabeprazole regimens: 20mg once daily in the evening (dose administered 30minutes prior to the evening meal; "QPM" regimen), 10mg twice daily (dose administered 30minutes prior to the morning and evening meals; "BID/twice daily" regimen) or 20mg once daily in the morning (dose administered 30minutes prior to the morning meal; "QAM/every morning" regimen), plus antacids as required. The study hypothesis is that after failure to control night-time heartburn symptoms with other acid suppressive therapy, instituting rabeprazole will have a beneficial effect. Safety assessments include: physical examination and pregnancy test at screening, vital signs and weight at randomization and final visit, adverse event and concomitant medication reporting at every visit. Rabeprazole 20mg once daily in the evening: one rabeprazole 20mg tablet daily in the evening, 30-60 minutes before dinner for 56 days OR Rabeprazole 10mg twice daily: one rabeprazole 10mg tablet in the morning, 30-60 minutes before breakfast, and one rabeprazole 10mg tablet 30-60 minutes before dinner for 56 days. OR Rabeprazole 20mg once daily in the morning: one rabeprazole 20mg tablet daily in the morning, 30-60 minutes before breakfast for 56 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients must have had a minimum three-month history of symptomatic GERD, with heartburn as the predominant symptom, and must report nocturnal heartburn symptoms (i.e., heartburn symptoms experienced during the night-time period, between 2200 and 0600h)
- Patients must currently be taking a proton-pump inhibitor (PPI) or histamine-2 receptor antagonist (H2RA) at least four weeks prior to study admission
- Patients must be able to read, write and understand the language of the HRQOL and productivity assessment instruments (PAGI-SYM, PAGI-QOL, WPAI-GH) i.e., English or French
- Patients must have been at least 80% compliant with their current acid suppressive therapy, and must have completed a minimum of 11 of 14 nocturnal heartburn ratings during the run-in period (i.e. <=3 "missing" nocturnal heartburn ratings during the 14-day period)
- Patients must have a total nocturnal heartburn symptom score of >4 points during the 2-week run-in period
Key exclusion criteria (13 listed)
- Patients currently taking rabeprazole 20mg once daily (morning or evening administration) or 10mg twice daily (morning and evening administration) on a continuous basis
- Documented evidence of GERD refractory to acid suppressive therapy (i.e.
- no or poor clinical response to at least two treatment courses of 4-weeks duration with a PPI)
- Esophagitis known to be the result of systemic events (e.g. scleroderma, ingested irritants)
- Active GI bleeding, or presence of "alarm symptoms" (i.e., vomiting, blood in stool, anemia, dysphagia)
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 | Drug | – |
Primary outcome
The primary analysis will be based on the mean nocturnal heartburn score observed after four weeks of drug administration for each of the three dosing regimens of rabeprazole.
1 secondary outcome
Nocturnal heartburn score at end of treatment/ 8 weeks; HRQoL and productivity outcomes 4 & 8 wks; rescue meds usage & compliance with study meds over entire study; day-time heartburn score 4 & 8 wks.
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 17 May 2011.
- A randomized, controlled, parallel-group, open-label study to evaluate different dosing regimens of rabeprazole in controlling nocturnal heartburn symptoms in patients with gastroesophageal reflux diseaseLink provided by the sponsor.
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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.
Janssen-Ortho Inc. Clinical Trial study director
Janssen-Ortho Inc., Canada
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing rabeprazole in people with Gastroesophageal Reflux and Heartburn, run by Janssen-Ortho Inc., Canada.
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 7 inclusion and 13 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 17 May 2011. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
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 primary analysis will be based on the mean nocturnal heartburn score observed after four weeks of drug administration for each of the three dosing regimens of rabeprazole.. 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 17 May 2011; AzTrials last refreshed its copy on 6 Nov 2026.