Gastroesophageal Reflux DiseasePhase 3DRNERDNCT01391715
Double-dose Rabeprazole Accelerates and Sustains the Control of Symptoms in Patients With NERD
A Phase 3 study testing rabeprazole and standard dose rabeprazole in people with Gastroesophageal Reflux Disease, run by Inje University at 1 site in South Korea.
Trial summary
To the best of our knowledge, there has been no randomized controlled trial to compare double dose PPI therapy with standard one dose PPI therapy for NERD patients. Thus, we hypothesize that a double dose PPI would accelerate and sustain the control of symptom in NERD patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroesophageal Reflux Disease
- What is being tested?
- rabeprazole and standard dose rabeprazole
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2011to Dec 2012
- 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
- heartburn and/or reflux at least twice weekly in the absence of visible esophageal mucosal breaks at endoscopy
Who cannot join
- pregnancy
- lactation
- Hx of gastric surgery
- Hx of gastric cancer or peptic ulcer
- major medical problems (including CHF, renal failure, COPD, asthma, liver cirrhosis)
- severe systemic illness
Show all 11Show fewer
- Hx of malignancy, allergy Hx to rabeprazole
- patients who had taken antibiotics
- antisecretory agents including H2-blocker
- PPI within 4 weeks before endoscopy
- current usage of steroids, NSAIDs, aspirin, anticoagulant medication
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Haeundae Paik Hospital, Inje University School of Medicine
Busan, 612-030
About this study
Official title: Double-dose Rabeprazole Accelerates and Sustains the Control of Symptoms in Patients With NERD: a Randomized Controlled Trial
To the best of our knowledge, there has been no randomized controlled trial to compare double dose PPI therapy with standard one dose PPI therapy for NERD patients. Thus, we hypothesize that a double dose PPI would accelerate and sustain the control of symptom in NERD patients.
Read the detailed description
In Asian, the majority of GERD cases are cases of nonerosive reflux esophagitis(NERD). NERD is a difficult -to-treat acid reflux condition even with PPI compared to reflux esophagitis(RE). In addition, the quality of life of NERD patients is quite low, NERD patients need quicker and more effective treatment options. At present, PPI-based step-down treatment is recommended for GERD patients. Doubling th PPI dose has become a commonly practiced therapeutic strategy in patients with GERD who failed PPI once daily. In patients with symptomatic GERD who failed the one dose PPI can increase the rate of overall symptom improvement by 22-26%. There are various mechanisms for standard dose PPI failure in GERD patients. Esophageal hypersensitivity is likely the underlying mechanism in a significant number of patients. Patients with the sensitive esophagus (normal endoscopy and pH test but positive symptom index) were more likely to respond to PPI twice a day. It is thus of clinical interest to determine whether an increased dosage of PPI can achieve rapidly the control of symptoms for patient with NERD patients.
- Conditions
- Gastroesophageal Reflux Disease
- Being tested
- rabeprazole, standard dose rabeprazole
- Keywords
- Gastroesophageal reflux disease, Proton pump inhibitor, standard dose, Double dose
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rabeprazoleDrug
rabeprazole 20mg bid per day for 2 weeks
standard dose rabeprazoleDrug
rabeprazole 20mg qd per day for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Double dose rabeprazole | Active comparator | Rabeprazole 20m bid per day will be given for 2 weeks Receives: Drug: rabeprazole |
| standard dose rabeprazole | Placebo comparator | rabeprazole 20mg per day will bi given for 2 weeks Receives: Drug: standard dose rabeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
symptom improvement at 2 week after double dose rabeprazole treatment
symptom improvement according to FSSG(the frequency scale for the symptoms of GERD) at 2 week after double dose rabeprazole treatment
Measured: Two weeks
Secondary outcomes (1)
sustained symptom improvement at 6 week after treatment
sustained symptom improvement assessed by FSSG(the frequency scale for the symptoms of GERD)score at 6 week after treatment
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2011 (estimated)
- Study startAug 2011
- Primary completionOct 2012 (estimated)
- Study completionDec 2012 (estimated)
Why it stopped: patients could not be recuited within study duration
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal Reflux DiseaseStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inje University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eun Hee Seo, Inje University
- Investigators
- Tae Oh Kim, M.D. PhD., Study director, Internal Medicine, Haeundae Paik HospitalEun Hee Seo, M.D, Principal investigator, Internal Medicine, Haeundae Paik Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01391715
- Sponsor's protocol ID
- 01July2011
- Acronym
- DRNERD
- Status last verified
- Jan 2012
- First submitted
- 11 Jul 2011
- Last updated
- 18 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-dose Rabeprazole Accelerates and Sustains the Control of Symptoms in Patients With NERD: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01391715
- Acronym / sponsor ID
- DRNERD / 01July2011
- Conditions
- Gastroesophageal Reflux Disease
- Keywords
- Gastroesophageal reflux disease, Proton pump inhibitor, standard dose, Double dose
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: patients could not be recuited within study duration
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Inje UniversityUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Oct 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 12 Jul 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.
To the best of our knowledge, there has been no randomized controlled trial to compare double dose PPI therapy with standard one dose PPI therapy for NERD patients. Thus, we hypothesize that a double dose PPI would accelerate and sustain the control of symptom in NERD patients.
Detailed description
In Asian, the majority of GERD cases are cases of nonerosive reflux esophagitis(NERD). NERD is a difficult -to-treat acid reflux condition even with PPI compared to reflux esophagitis(RE). In addition, the quality of life of NERD patients is quite low, NERD patients need quicker and more effective treatment options. At present, PPI-based step-down treatment is recommended for GERD patients. Doubling th PPI dose has become a commonly practiced therapeutic strategy in patients with GERD who failed PPI once daily. In patients with symptomatic GERD who failed the one dose PPI can increase the rate of overall symptom improvement by 22-26%. There are various mechanisms for standard dose PPI failure in GERD patients. Esophageal hypersensitivity is likely the underlying mechanism in a significant number of patients. Patients with the sensitive esophagus (normal endoscopy and pH test but positive symptom index) were more likely to respond to PPI twice a day. It is thus of clinical interest to determine whether an increased dosage of PPI can achieve rapidly the control of symptoms for patient with NERD patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Double dose rabeprazole | Active comparator | Drug: rabeprazoleRabeprazole 20m bid per day will be given for 2 weeks |
| standard dose rabeprazole | Placebo comparator | Drug: standard dose rabeprazolerabeprazole 20mg per day will bi given for 2 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- heartburn and/or reflux at least twice weekly in the absence of visible esophageal mucosal breaks at endoscopy
Key exclusion criteria (11 listed)
- pregnancy
- lactation
- Hx of gastric surgery
- Hx of gastric cancer or peptic ulcer
- major medical problems (including CHF, renal failure, COPD, asthma, liver cirrhosis)
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 |
|---|---|---|
| rabeprazolerabeprazole 20mg bid per day for 2 weeks | Drug | Double dose rabeprazole |
| standard dose rabeprazolerabeprazole 20mg qd per day for 2 weeks | Drug | standard dose rabeprazole |
Primary outcome
symptom improvement at 2 week after double dose rabeprazole treatment
Time frame: Two weeks
symptom improvement according to FSSG(the frequency scale for the symptoms of GERD) at 2 week after double dose rabeprazole treatment
1 secondary outcome
sustained symptom improvement at 6 week after treatment
Time frame: 6 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2012.
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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.
Tae Oh Kim, M.D. PhD. study director
Internal Medicine, Haeundae Paik Hospital
Eun Hee Seo, M.D principal investigator
Internal Medicine, Haeundae Paik Hospital
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 and standard dose rabeprazole in people with Gastroesophageal Reflux Disease, run by Inje University at 1 site in South Korea.
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 1 inclusion and 11 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: withdrawn, as of the sponsor's last update on 18 Jan 2012. 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 South Korea. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
symptom improvement at 2 week after double dose rabeprazole treatment (time frame: Two weeks). 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 18 Jan 2012.