Non-erosive Gastroesophageal Reflux DiseasePhase 3NCT00165672
A Study of E3810 With Pre- and Post-Treatment pH Monitoring in Patients With Non-Erosive Gastroesophageal Reflux Disease
A Phase 3 study testing RABEPRAZOLE SODIUM in people with Non-erosive Gastroesophageal Reflux Disease, run by Eisai Inc. at 13 sites in Japan.
Trial summary
To investigate esophageal reflux condition in patients with non-erosive gastroesophageal reflux disease by assessing with a 24-hour esophageal pH monitoring or effects of a 4-week treatment with 5 mg/day or 10 mg/day of E3810 (Pariet (Rabeprazole Sodium)). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Non-erosive Gastroesophageal Reflux Disease
- What is being tested?
- RABEPRAZOLE SODIUM
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 13 sitesJapan
- Study dates
- May 2005to Oct 2005
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patients to be included will be outpatients who meet all of the following criteria. No specific gender is asked.
- <For the observation period>
- Patients who have "heartburn" 2 days a week or more during consecutive 3 weeks* prior to pre-observation screening. *If a day of screening and a day of starting observation (date of registration) are different, heartburn must continuously be present during the in-between period.
- Patients who meet both 1) and 2) below;
- 1) The symptom is a burning sensation arising from the stomach or the lower chest.
- 2) The symptom tends to appear frequently or is aggravated after eating, when bending a body forward, and/or when pressing on the abdomen.
Show all 14Show fewer
- 3. Patients categorized in "grade M" (discoloring type: minimal change) according to the Los Angeles System (2nd Modification) for Classification of Reflux Esophagitis.
- 4. Patients who are 20 years old or older at the time of obtaining consent.
- 5. Patients who are informed of the objective and details of this study and give written consent for study entry.
- <For the treatment period>
- Patients who have "heartburn" 2 days a week or more during 7 days until the treatment period (during the observation period).
- Patients with "heartburn diary" that is completely filled out during 7 days until the treatment period (during the observation period). If the observation period is 8 days or longer, those with a heartburn diary of which entries are fulfilled 80% or more during the observation period.
- Patients with 80% or better drug compliance for antacids during the observation period.
- Patients whose percentage of time showing pH<4.0 (% time pH<4.0) is not 0%* during the 24-hour esophageal pH monitoring at the end of observation period (at the beginning of treatment period). *If parameters calculated from analytical program show 0.0% after round-off, this patient cannot be entered into the treatment period.
Who cannot join
- Patients who meet any of the following criteria will be excluded from the study.
- Patients who cannot keep adequate entries of a heartburn diary by themselves.
- Patients who strongly complain "feeling of heavy stomach" and/or "abdominal bloating."
- Patients who have a complication or history of psychiatric or psychosomatic disease (e.g., manic-depressive psychosis, obsessive-compulsive neurosis, or others) or those who are on an antidepressant or anti-anxiety agent (accepted if only for a hypnotic treatment).
- Patients who have undergone Helicobacter pylori eradication therapy, and less than 6 months* have elapsed from the end of H. pylori eradication therapy to the beginning of the observation period. *: The same day 6 months earlier, and the day at the end of 6 months earlier if it is at the end of month.
- Patients with open gastric or duodenal ulcer.
Show all 20Show fewer
- Patients with acute gastritis.
- Patients with a history of any surgical intervention that affect peptic secretion (e.g., upper gastrointestinal tract resection and/or vagotomy).
- Patients with Barrett's esophagus, esophageal stenosis, or pyloric stenosis.
- Patients with scleroderma.
- Patients with a history or complication of angina pectoris.
- Patients who work at night (working for a night-shift).
- Patients who received proton pump inhibitors (PPIs) within 3 weeks prior to pre-observation screening.
- Patients who need non steroidal anti-inflammatory drugs (NSAIDs) (except topical preparations), steroids (except topical preparations), and/or aspirin treatment every day.
- Patients receiving dialysis therapy.
- Patients with a serious complication such as cardiovascular disease (myocardial infarction, etc.), hematological disorder (e.g, aplastic anemia), renal disease (e.g., acute or chronic renal failure), hepatic disease (e.g., cirrhosis), or malignant tumor.
- Patients with known hypersensitivity to antacids or PPIs.
- Patients who are pregnant or those with childbearing potential, or those who wish to become pregnant or are lactating during the study period.
- Patients receiving another investigational drug or those who received another investigational drug within 6 months prior to pre-observation screening* *: Registration is allowed on the same day of 6 months earlier, and the day at the end of 6 months earlier if it is at the end of month.
- Patients who are judged to be ineligible for the study entry by the investigator or subinvestigator.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Japan13 sites
Study site
Bunkyo-ku, Tokyo, 113-0022
Study site
Fukuoka, Fukuoka, 810-0001
Study site
Fukuoka, Fukuoka, 811-0213
Study site
Hiroshima, Hiroshima, 734-0037
Study site
Izumo, Shimane, 693-0021
Study site
Nagoya, Aichi-ken, 467-0001
Study site
Osaka, Osaka, 530-0012
Study site
Osaka, Osaka, 545-0051
Study site
Ōtsu, Shiga, 520-2121
Study site
Saga, Saga-ken, 849-0937
Study site
Shinjuku-ku, Tokyo, 162-0052
Study site
Ube, Yamaguchi, 755-0046
Study site
Yukuhashi, Fukuoka, 824-0026
About this study
Official title: A Clinical Pharmacology Study of E3810 With Pre- and Post-Treatment pH Monitoring in Patients With Non-Erosive Gastroesophageal Reflux Disease
To investigate esophageal reflux condition in patients with non-erosive gastroesophageal reflux disease by assessing with a 24-hour esophageal pH monitoring or effects of a 4-week treatment with 5 mg/day or 10 mg/day of E3810 (Pariet (Rabeprazole Sodium)).
- Being tested
- RABEPRAZOLE SODIUM
- Keywords
- 24-hour esophageal pH monitoring, non-erosive gastroesophageal reflux disease, NERD, proton pump inhibitor, rabeprazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RABEPRAZOLE SODIUMDrug
rabeprazole sodium 5 mg: once daily orally for 4 weeks
RABEPRAZOLE SODIUMDrug
rabeprazole sodium 10 mg: once daily orally for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: RABEPRAZOLE SODIUM |
| 2 | Experimental | Not described Receives: Drug: RABEPRAZOLE SODIUM |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Percent Time With pH <4.0 During 24 Hour Esophageal pH Monitoring at the End of the Observation Period (Predose Monitoring) and at the End of the Treatment Period (Postdose Monitoring).
Mean and standard deviation of percent time pH<4.0 on 24 hour esophageal pH monitoring.
Measured: Baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startMay 2005
- Primary completionOct 2005
- Study completionOct 2005
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 Non-erosive Gastroesophageal Reflux DiseaseStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eisai Limited
- Investigators
- Nobuyuki Sugisaki, Study director, Eisai Co., Ltd - Development Clinical Research Department. Clinical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00165672
- Sponsor's protocol ID
- E3810-J081-462
- Status last verified
- Aug 2010
- First submitted
- 12 Sep 2005
- Last updated
- 5 Oct 2011
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Pharmacology Study of E3810 With Pre- and Post-Treatment pH Monitoring in Patients With Non-Erosive Gastroesophageal Reflux Disease
- ClinicalTrials.gov ID
- NCT00165672
- Acronym / sponsor ID
- E3810-J081-462
- Keywords
- 24-hour esophageal pH monitoring, non-erosive gastroesophageal reflux disease, NERD, proton pump inhibitor, rabeprazole
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Collaborators
- Eisai Limited
- Study start
- May 2005
- Primary completion
- Oct 2005 (actual)
- Study completion
- Oct 2005 (actual)
- First posted
- 14 Sep 2005 (estimated)
- Results
- Posted 5 Oct 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate esophageal reflux condition in patients with non-erosive gastroesophageal reflux disease by assessing with a 24-hour esophageal pH monitoring or effects of a 4-week treatment with 5 mg/day or 10 mg/day of E3810 (Pariet (Rabeprazole Sodium)).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: RABEPRAZOLE SODIUM |
| 2 | Experimental | Drug: RABEPRAZOLE SODIUM |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- The patients to be included will be outpatients who meet all of the following criteria. No specific gender is asked.
- <For the observation period>
- Patients who have "heartburn" 2 days a week or more during consecutive 3 weeks* prior to pre-observation screening. *If a day of screening and a day of starting observation (date of registration) are different, heartburn must continuously be present during the in-between period.
- Patients who meet both 1) and 2) below;
- 1) The symptom is a burning sensation arising from the stomach or the lower chest.
Key exclusion criteria (20 listed)
- Patients who meet any of the following criteria will be excluded from the study.
- Patients who cannot keep adequate entries of a heartburn diary by themselves.
- Patients who strongly complain "feeling of heavy stomach" and/or "abdominal bloating."
- Patients who have a complication or history of psychiatric or psychosomatic disease (e.g., manic-depressive psychosis, obsessive-compulsive neurosis, or others) or those who are on an antidepressant or anti-anxiety agent (accepted if only for a hypnotic treatment).
- Patients who have undergone Helicobacter pylori eradication therapy, and less than 6 months* have elapsed from the end of H. pylori eradication therapy to the beginning of the observation period. *: The same day 6 months earlier, and the day at the end of 6 months earlier if it is at the end of month.
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 5 mg: once daily orally for 4 weeks | Drug | 1 |
| RABEPRAZOLE SODIUMrabeprazole sodium 10 mg: once daily orally for 4 weeks | Drug | 2 |
Primary outcome
The Percent Time With pH <4.0 During 24 Hour Esophageal pH Monitoring at the End of the Observation Period (Predose Monitoring) and at the End of the Treatment Period (Postdose Monitoring).
Time frame: Baseline and 4 weeks
Mean and standard deviation of percent time pH<4.0 on 24 hour esophageal pH monitoring.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Non-erosive Gastroesophageal Reflux Disease
RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Vonoprazan 10 mg Compared to Placebo for Relief of Episodic Heartburn in Participants With Symptomatic Non-Erosive Gastroesophageal Reflux Disease Through 24 Weeks
Symptomatic Non-erosive Gastroesophageal Reflux Disease
RecruitingObservational study
A Study of the Safety of Vonoprazan Exposure in Pregnant Women and Their Offspring
Erosive Esophagitis, Heartburn
Not yet recruiting
Mirgeal® Gel as Add-on Therapy to Esomeprazole in Adults With Non-Erosive Gastroesophageal Reflux Disease
Non-Erosive Gastroesophageal Reflux Disease (NERD)
Not yet recruitingPhase 3
Phase 3 Study of JP-1366: Efficacy and Safety of JP-1366 as Maintenance Therapy in Subjects With Healed Erosive Esophagitis
Maintenance of Healed Erosive Gastroesophageal Reflux Disease (ERD)
Recruiting
QUality of Sleep Improvement With Evening Topical Therapy for Non-Erosive Gastroesophageal Reflux Disease (The QUIET Trial)
Nocturnal Symptoms of GERD, Sleep Disorders in GERD
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.
Nobuyuki Sugisaki study director
Eisai Co., Ltd - Development Clinical Research Department. Clinical Research Center
13 sites 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 Non-erosive Gastroesophageal Reflux Disease, run by Eisai Inc. at 13 sites in Japan.
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 14 inclusion and 20 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 5 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Japan. 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.
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 5 Oct 2011). 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?
The Percent Time With pH <4.0 During 24 Hour Esophageal pH Monitoring at the End of the Observation Period (Predose Monitoring) and at the End of the Treatment Period (Postdose Monitoring). (time frame: Baseline and 4 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 5 Oct 2011.