Trial · NCT02135107
A Double-blind Comparative Study of the Efficacy and Safety of E3810 10mg Once and Twice Daily in Maintenance Therapy for PPI Resistant Gastroesophageal Reflux Disease Patients
NCT02135107, Phase 3, Completed, Eisai Co., Ltd.; results first posted 2018-11-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Double-blind Comparative Study of the Efficacy and Safety of E3810 10mg Once and Twice Daily in Maintenance Therapy for PPI Resistant Gastroesophageal Reflux Disease Patients. Trials, record NCT02135107. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02135107
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Double-blind Comparative Study of the Efficacy and Safety of E3810 10mg Once and Twice Daily in Maintenance Therapy for PPI Resistant Gastroesophageal Reflux Disease Patients
- NCT number
- NCT02135107
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 517 participants, actual
- Lead sponsor
- Eisai Co., Ltd.
- Conditions
- Gastroesophageal Reflux Disease
- Interventions
- Rabeprazole, Rabeprazole, Rabeprazole, Rabeprazole
- First posted
- 2014-05-09
- Last updated
- 2023-06-22
- Results first posted
- 2018-11-19
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Rate of Non-recurrence at Week 52 | Week 52 | The non-recurrence rate (at 52 weeks) was determined by the endoscopy central review panel who were blinded to the investigator's assessment, based on the modified Los Angeles Classification using endoscopy photos were submitted by each of the institutions. Participants showing Grade A or above based on the modified Los Angeles Classification were included as a recurrence. |
| Secondary | Rate of Non-recurrence at Weeks 12 and 24 | Weeks 12 and 24 | The non-recurrence rate (up to 52 weeks) was determined by the endoscopy central review panel who were blinded to the investigator's assessment, based on the modified Los Angeles Classification using endoscopy photos were submitted by each of the institutions. Participants showing Grade A or above based on the modified Los Angeles Classification were included as a recurrence. The 95% CI was calculated by normal approximation. |
| Secondary | Cumulative Non-recurrence Rate at Week 52 | Week 52 | Non-recurrence rate at Week 52 was estimated using the Kaplan-Meier method. |
| Secondary | Percentage of Participants With Heartburn (Daytime / Nighttime) During the Maintenance Therapy Period | From Week 4 up to Week 52 | A comparison of the rabeprazole 10 mg once daily group and the rabeprazole 10 mg twice daily group was performed for participants who did not exhibit daytime or nighttime heartburn at Week 0 of the Maintenance Therapy Period. Heartburn is a burning sensation in the stomach or lower chest; it is worsened by bending or pressure on the abdomen. Heartburn frequency was rated from 0-day (no) to 7-day (always) and severity was graded on a 3-point scale (mild, moderate, severe). Heartburn was evaluated in the daytime (from wake-up time to time for bed) and nighttime (from time for bed to wake-up time). |
| Secondary | Frequency of Heartburn (Daytime / Nighttime) During the Maintenance Therapy Period | From Week 4 up to Week 52 | A comparison of rabeprazole 10 mg once daily group and the rabeprazole 10 mg twice daily group shall be performed for participants who did not exhibit daytime or nighttime heartburn at 0 weeks of the maintenance therapy period. Daytime and nighttime heartburn, and nighttime sleep disorders shall likewise be compared. For the participants who had recurrence, values at the final evaluation were imputed using a last observation carried forward (LOCF) method. |
| Secondary | Severity of Heartburn (Daytime / Nighttime) During the Maintenance Therapy Period | From Week 4 up to Week 52 | A comparison of the rabeprazole (10 mg once daily group) and the rabeprazole (10 mg twice daily group) was performed for participants who did not exhibit daytime or nighttime heartburn at Week 0 of the Maintenance Therapy Period. The presence or absence of heartburn was assessed by the investigators during medical interviews. The heartburn incidence during each of the 7-day periods immediately before visiting the hospital was assessed on a scale of five stages based on the number of days with symptoms: 0 (no symptoms), 1 to 2 (occasional symptoms), 3 to 4 (sometimes had symptoms), 5 to 6 (often had symptoms), and 7 (always had symptoms). The incidence was tabulated by an analysis classifying the states into two groups: "no symptom group" (0 days with symptoms) and "with symptoms group" (1 day or more with symptoms). The severity of heartburn was as below: Mild (feel heartburn but tolerable), Moderate (feel heartburn and hard), and Severe (feel heartburn and terrible). |
| Secondary | Percentage of Participants With Sleep Disorders During the Maintenance Therapy Period | From Week 4 up to Week 52 | Sleep disorders were defined as the condition of lack of dead sleep and arousal during sleep arising from heartburn or acid reflux. Sleep disorders during each of the 7-day periods immediately before visiting the hospital were assessed. Evaluation of sleep disorders arising from heartburn or acid reflux included recording if sleep-inducing drugs were being taken before enrollment; their type, method of use, and dosage. It was requested that no changes in sleep-inducing drug be made after enrollment. Sleep disorders were rated from 0-day (no) to 7-day (always). The incidence of sleep disorder was tabulated by an analysis classifying the stages into two groups: "No" (0 days with sleep disorder) and "Yes" (1 or more days with sleep disorder). Heartburn was evaluated prior to 7 days of each visit. |
| Secondary | Frequency of Sleep Disorders During the Maintenance Therapy Period | From Week 4 up to Week 52 | Sleep disorders were defined as the condition of lack of dead sleep and arousal during sleep arising from heartburn or acid reflux. Evaluation of sleep disorders arising from heartburn or acid reflux included recording if sleep-inducing drugs were being taken before enrollment; their type, method of use, and dosage. It was requested that no changes in sleep-inducing drug be made after enrollment. Sleep disorders were rated from 0-day (no) to 7-day (always). Heartburn was evaluated prior to 7 days of each visit. |
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days) | Safety was assessed by monitoring and recording all adverse events (AEs) and SAEs, regular monitoring of hematology, clinical chemistry, urine values, and regular measurement of vital signs. All AEs were graded on a 3-point scale; 1) mild was defined as discomfort that did not interfere with normal daily activities, 2) moderate was defined as discomfort that interfered with normal activities, and 3) severe was defined as discomfort that interfered with the ability to work or normal daily activities were impossible. SAEs were medical events that led to death, were life-threatening, required hospitalization or prolongation of hospitalization, caused persistent disability, or resulted in a congenital abnormality. TEAEs were AEs with an onset date on or after the first dose of study drug and up to 30 days after receiving the last dose of study drug. Treatment-related AEs were medical events that were considered by the investigator to be possibly or probably related to rabeprazole. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Rate of Non-recurrence at Week 52 | Week 52 | Central assessment Full Analysis Set (FAS) was defined as all randomized participants who received at least one dose of the study drug, and from whom the results of at least one endoscopic assessment was available. Data analysis excluded participants with missing data. | Percentage of participants | NUMBER |
| SECONDARY | Rate of Non-recurrence at Weeks 12 and 24 | Weeks 12 and 24 | Central assessment FAS. Data analysis excluded participants with missing data. | Percentage of participants | NUMBER |
| SECONDARY | Cumulative Non-recurrence Rate at Week 52 | Week 52 | Central assessment FAS | Percentage of non-recurrence | NUMBER |
| SECONDARY | Percentage of Participants With Heartburn (Daytime / Nighttime) During the Maintenance Therapy Period | From Week 4 up to Week 52 | Central assessment FAS - LOCF. Analysis was carried out on participants who were determined to be free of symptoms at maintenance therapy entry. | Percentage of participants | NUMBER |
| SECONDARY | Frequency of Heartburn (Daytime / Nighttime) During the Maintenance Therapy Period | From Week 4 up to Week 52 | Central assessment FAS | Percentage of participants | NUMBER |
| SECONDARY | Severity of Heartburn (Daytime / Nighttime) During the Maintenance Therapy Period | From Week 4 up to Week 52 | Central assessment FAS - LOCF | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Sleep Disorders During the Maintenance Therapy Period | From Week 4 up to Week 52 | Central assessment FAS. Participants who did not have sleep disorder due to nighttime heartburn or swallowing at the time of maintenance of the Maintenance Therapy Period, participants whose visit data was not missing. | Percentage of participants | NUMBER |
| SECONDARY | Frequency of Sleep Disorders During the Maintenance Therapy Period | From Week 4 up to Week 52 | Central assessment FAS | Percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | From date of first dose up to 30 days after the last dose of study drug, up to approximately 1 year 3 months (Treatment Period; 8 weeks, Maintenance Therapy Period; 52 weeks, and Follow-up Period; 30 days) | Safety analysis set was the group of participants who received at least one dose of study drug (rabeprazole) in the Treatment Period or Maintenance Period and had at least one post-dose safety assessment. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group66
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Rate of Non-recurrence at Week 52 | Rabeprazole: 10 or 20 mg Twice Daily, Then 10 mg Once Daily | Non-recurrence | 44.8 | 95% Confidence Interval 37.2 to 52.4 | Percentage of participants |
| Rate of Non-recurrence at Week 52 | Rabeprazole: 10 or 20 mg Twice Daily, Then 10 mg Twice Daily | Non-recurrence | 73.9 | 95% Confidence Interval 67.1 to 80.7 | Percentage of participants |
| Rate of Non-recurrence at Week 52 | Rabeprazole: 10 or 20 mg Twice Daily, Then 10 mg Once Daily | Recurrence | 55.2 | 95% Confidence Interval NA to NA | Percentage of participants |
| Rate of Non-recurrence at Week 52 | Rabeprazole: 10 or 20 mg Twice Daily, Then 10 mg Twice Daily | Recurrence | 26.1 | 95% Confidence Interval NA to NA | Percentage of participants |
| Rate of Non-recurrence at Weeks 12 and 24 | Rabeprazole: 10 or 20 mg Twice Daily, Then 10 mg Once Daily | Week 12, Non-recurrence | 62.5 | 95% Confidence Interval 55.2 to 69.8 | Percentage of participants |
| Rate of Non-recurrence at Weeks 12 and 24 | Rabeprazole: 10 or 20 mg Twice Daily, Then 10 mg Twice Daily | Week 12, Non-recurrence | 92.4 | 95% Confidence Interval 88.4 to 96.4 | Percentage of participants |
| Rate of Non-recurrence at Weeks 12 and 24 | Rabeprazole: 10 or 20 mg Twice Daily, Then 10 mg Once Daily | Week 12, Recurrence | 37.5 | 95% Confidence Interval NA to NA | Percentage of participants |
| Rate of Non-recurrence at Weeks 12 and 24 | Rabeprazole: 10 or 20 mg Twice Daily, Then 10 mg Twice Daily | Week 12, Recurrence | 7.6 | 95% Confidence Interval NA to NA | Percentage of participants |
| Rate of Non-recurrence at Weeks 12 and 24 | Rabeprazole: 10 or 20 mg Twice Daily, Then 10 mg Once Daily | Week 24, Non-recurrence | 55.8 | 95% Confidence Interval 48.2 to 63.3 | Percentage of participants |
| Rate of Non-recurrence at Weeks 12 and 24 | Rabeprazole: 10 or 20 mg Twice Daily, Then 10 mg Twice Daily | Week 24, Non-recurrence | 85.1 | 95% Confidence Interval 79.7 to 90.5 | Percentage of participants |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment Period | STARTED | Rabeprazole: 10 mg Twice Daily | 437 | |
| Treatment Period | STARTED | Rabeprazole: 20 mg Twice Daily | 80 | |
| Treatment Period | STARTED | Rabeprazole: 10 or 20 mg Twice Daily, Then 10 mg Once Daily | 0 | |
| Treatment Period | STARTED | Rabeprazole: 10 or 20 mg Twice Daily, Then 10 mg Twice Daily | 0 | |
| Treatment Period | COMPLETED | Rabeprazole: 10 mg Twice Daily | 305 | |
| Treatment Period | COMPLETED | Rabeprazole: 20 mg Twice Daily | 54 | |
| Treatment Period | COMPLETED | Rabeprazole: 10 or 20 mg Twice Daily, Then 10 mg Once Daily | 0 | |
| Treatment Period | COMPLETED | Rabeprazole: 10 or 20 mg Twice Daily, Then 10 mg Twice Daily | 0 | |
| Treatment Period | NOT COMPLETED | Rabeprazole: 10 mg Twice Daily | 132 | |
| Treatment Period | NOT COMPLETED | Rabeprazole: 20 mg Twice Daily | 26 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events244
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Rabeprazole: 10 mg Twice Daily | 4 | 437 | |
| other | Diarrhoea | Gastrointestinal disorders | Rabeprazole: 20 mg Twice Daily | 0 | 80 | |
| other | Diarrhoea | Gastrointestinal disorders | Rabeprazole: 10 or 20 mg Twice Daily, Then 10 mg Once Daily | 3 | 178 | |
| other | Diarrhoea | Gastrointestinal disorders | Rabeprazole: 10 or 20 mg Twice Daily, Then 10 mg Twice Daily | 10 | 181 | |
| other | Dental caries | Gastrointestinal disorders | Rabeprazole: 10 mg Twice Daily | 0 | 437 | |
| other | Dental caries | Gastrointestinal disorders | Rabeprazole: 20 mg Twice Daily | 1 | 80 | |
| other | Dental caries | Gastrointestinal disorders | Rabeprazole: 10 or 20 mg Twice Daily, Then 10 mg Once Daily | 7 | 178 | |
| other | Dental caries | Gastrointestinal disorders | Rabeprazole: 10 or 20 mg Twice Daily, Then 10 mg Twice Daily | 3 | 181 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Rabeprazole: 10 mg Twice Daily | 1 | 437 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Rabeprazole: 20 mg Twice Daily | 0 | 80 |
1 to 10 of 244Source ClinicalTrials.gov
See all 244 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Rabeprazole: 10 mg Twice Daily | 0 | 437 |
| Total, all-cause mortality | Rabeprazole: 20 mg Twice Daily | 0 | 80 |
| Total, all-cause mortality | Rabeprazole: 10 or 20 mg Twice Daily, Then 10 mg Once Daily | 1 | 178 |
| Total, all-cause mortality | Rabeprazole: 10 or 20 mg Twice Daily, Then 10 mg Twice Daily | 0 | 181 |
| Total, other adverse events | Rabeprazole: 10 mg Twice Daily | 63 | 437 |
| Total, other adverse events | Rabeprazole: 20 mg Twice Daily | 12 | 80 |
| Total, other adverse events | Rabeprazole: 10 or 20 mg Twice Daily, Then 10 mg Once Daily | 75 | 178 |
| Total, other adverse events | Rabeprazole: 10 or 20 mg Twice Daily, Then 10 mg Twice Daily | 87 | 181 |
| Total, serious adverse events | Rabeprazole: 10 mg Twice Daily | 6 | 437 |
| Total, serious adverse events | Rabeprazole: 20 mg Twice Daily | 4 | 80 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 29188387 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02135107
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