Trial · NCT01089543
A Study of E3810 for Japanese Subjects With Functional Dyspepsia (SAMURAI Study: Suppression of Acid Milieu With Rabeprazole Improving Functional Dyspepsia ) (Study E3810-J081-204)
NCT01089543, Phase 2, Completed, Eisai Co., Ltd.; results first posted 2013-11-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of E3810 for Japanese Subjects With Functional Dyspepsia (SAMURAI Study: Suppression of Acid Milieu With Rabeprazole Improving Functional Dyspepsia ) (Study E3810-J081-204). Trials, record NCT01089543. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01089543
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of E3810 for Japanese Subjects With Functional Dyspepsia (SAMURAI Study: Suppression of Acid Milieu With Rabeprazole Improving Functional Dyspepsia ) (Study E3810-J081-204)
- NCT number
- NCT01089543
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 338 participants, actual
- Lead sponsor
- Eisai Co., Ltd.
- Conditions
- Functional Dyspepsia
- Interventions
- Rabeprazole, Rabeprazole, Rabeprazole, Placebo
- First posted
- 2010-03-18
- Last updated
- 2013-12-24
- Results first posted
- 2013-11-19
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Rate of Complete Dyspepsia Symptom Relief | Up to 8 Weeks (including 7 days prior) | The rate of complete dyspepsia symptom relief according to the Dyspepsia Symptom Questionnaire (DSQ) was defined as a score of 1 for all four major dyspeptic symptoms at week 8 and according to the diary defined as all four dyspepsia symptoms recorded absent during the 7 days prior to week 8. Values presented as percentage of participants. |
| Secondary | Rate of Satisfactory Symptom Relief | Up to 8 Weeks (including 7 days prior) | The rate of satisfactory symptom relief according to the DSQ defined as scores of \<= 2 for all four major dyspepsia symptoms at week 8 and the diary recordings defined as a frequency of \<= 1 day for all four major dyspepsia symptoms during the 7 days before week 8. Lastly, treatment success according to the participants' impression questionnaire where participants answered "yes" or "no" when asked if given the choice, whether they would want to continue to take the study drug after clinical trial completion. Values presented as percentage of participants. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Rate of Complete Dyspepsia Symptom Relief | Up to 8 Weeks (including 7 days prior) | Per Protocol Set (PPS) population defined as those participants who complied with the study protocol. | Percentage of Participants | NUMBER |
| SECONDARY | Rate of Satisfactory Symptom Relief | Up to 8 Weeks (including 7 days prior) | Per Protocol Set (PPS) Population: defined as those participants who complied with the study protocol. | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Rate of Complete Dyspepsia Symptom Relief | Rabeprazole 10 mg | DSQ (n= 76, n= 75, n= 74, n= 78) | 22.4 | Percentage of Participants | |
| Rate of Complete Dyspepsia Symptom Relief | Rabeprazole 20 mg | DSQ (n= 76, n= 75, n= 74, n= 78) | 29.3 | Percentage of Participants | |
| Rate of Complete Dyspepsia Symptom Relief | Rabeprazole 40 mg | DSQ (n= 76, n= 75, n= 74, n= 78) | 27.0 | Percentage of Participants | |
| Rate of Complete Dyspepsia Symptom Relief | Placebo | DSQ (n= 76, n= 75, n= 74, n= 78) | 17.9 | Percentage of Participants | |
| Rate of Complete Dyspepsia Symptom Relief | Rabeprazole 10 mg | Diary Recordings (n= 77, n= 76, n=74, n=80) | 22.1 | Percentage of Participants | |
| Rate of Complete Dyspepsia Symptom Relief | Rabeprazole 20 mg | Diary Recordings (n= 77, n= 76, n=74, n=80) | 28.9 | Percentage of Participants | |
| Rate of Complete Dyspepsia Symptom Relief | Rabeprazole 40 mg | Diary Recordings (n= 77, n= 76, n=74, n=80) | 27.0 | Percentage of Participants | |
| Rate of Complete Dyspepsia Symptom Relief | Placebo | Diary Recordings (n= 77, n= 76, n=74, n=80) | 17.5 | Percentage of Participants | |
| Rate of Satisfactory Symptom Relief | Rabeprazole 10 mg | DSQ (n=76, n=75, n=74, n=78) | 42.1 | Percentage of participants | |
| Rate of Satisfactory Symptom Relief | Rabeprazole 20 mg | DSQ (n=76, n=75, n=74, n=78) | 45.3 | Percentage of participants |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Rabeprazole 10 mg | 84 | |
| Overall Study | STARTED | Rabeprazole 20 mg | 85 | |
| Overall Study | STARTED | Rabeprazole 40 mg | 84 | |
| Overall Study | STARTED | Placebo | 85 | |
| Overall Study | COMPLETED | Rabeprazole 10 mg | 81 | |
| Overall Study | COMPLETED | Rabeprazole 20 mg | 81 | |
| Overall Study | COMPLETED | Rabeprazole 40 mg | 81 | |
| Overall Study | COMPLETED | Placebo | 83 | |
| Overall Study | NOT COMPLETED | Rabeprazole 10 mg | 3 | |
| Overall Study | NOT COMPLETED | Rabeprazole 20 mg | 4 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events64
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 | 3 | 85 | |
| other | Diarrhoea | Gastrointestinal disorders | Rabeprazole 20 mg | 3 | 85 | |
| other | Diarrhoea | Gastrointestinal disorders | Rabeprazole 40 mg | 2 | 83 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 2 | 85 | |
| other | Enterocolitis | Gastrointestinal disorders | Rabeprazole 10 mg | 0 | 85 | |
| other | Enterocolitis | Gastrointestinal disorders | Rabeprazole 20 mg | 0 | 85 | |
| other | Enterocolitis | Gastrointestinal disorders | Rabeprazole 40 mg | 2 | 83 | |
| other | Enterocolitis | Gastrointestinal disorders | Placebo | 0 | 85 | |
| other | Periodontitis | Gastrointestinal disorders | Rabeprazole 10 mg | 0 | 85 | |
| other | Periodontitis | Gastrointestinal disorders | Rabeprazole 20 mg | 0 | 85 |
1 to 10 of 64Source ClinicalTrials.gov
See all 64 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Rabeprazole 10 mg | ||
| Total, all-cause mortality | Rabeprazole 20 mg | ||
| Total, all-cause mortality | Rabeprazole 40 mg | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Rabeprazole 10 mg | 28 | 85 |
| Total, other adverse events | Rabeprazole 20 mg | 20 | 85 |
| Total, other adverse events | Rabeprazole 40 mg | 31 | 83 |
| Total, other adverse events | Placebo | 22 | 85 |
| Total, serious adverse events | Rabeprazole 10 mg | 0 | 85 |
| Total, serious adverse events | Rabeprazole 20 mg | 1 | 85 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23957383 | 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/NCT01089543
GET https://conductscience.org/api/trials/v1/NCT01089543/events?page=2