Trial · NCT00770913
Double-blind Comparative Study of E3810 Tablets (10 or 20 mg b.i.d.) to Evaluate Efficacy and Safety in Patients With Refractory Reflux Esophagitis
NCT00770913, Phase 2, Phase 3, Completed, Eisai Co., Ltd.; results first posted 2012-04-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Double-blind Comparative Study of E3810 Tablets (10 or 20 mg b.i.d.) to Evaluate Efficacy and Safety in Patients With Refractory Reflux Esophagitis. Trials, record NCT00770913. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00770913
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Double-blind Comparative Study of E3810 Tablets (10 or 20 mg b.i.d.) to Evaluate Efficacy and Safety in Patients With Refractory Reflux Esophagitis
- NCT number
- NCT00770913
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 337 participants, actual
- Lead sponsor
- Eisai Co., Ltd.
- Conditions
- Refractory Reflux Esophagitis
- Interventions
- E3810, E3810, E3810
- First posted
- 2008-10-10
- Last updated
- 2012-04-18
- Results first posted
- 2012-04-13
- Limitations and caveats
- In the Participant flow section, there is only one Reason for Not Completed per participant reported, even if there were multiple reasons.
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Healing Demonstrated Via Upper Gastrointestinal Endoscopy (Modified Los Angeles Classification: Grade N) | 8 weeks | Grade N indicates a normal appearance of lower esophageal mucosa |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Healing Demonstrated Via Upper Gastrointestinal Endoscopy (Modified Los Angeles Classification: Grade N) | 8 weeks | The primary analysis was on the full analysis set (FAS) population. | Percentage of Participants | NUMBER |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Healing Demonstrated Via Upper Gastrointestinal Endoscopy (Modified Los Angeles Classification: Grade N) | E3810 20 mg Once Daily | 58.8 | Percentage of Participants | ||
| Percentage of Participants With Healing Demonstrated Via Upper Gastrointestinal Endoscopy (Modified Los Angeles Classification: Grade N) | E3810 10 mg Twice Daily | 78.4 | Percentage of Participants | ||
| Percentage of Participants With Healing Demonstrated Via Upper Gastrointestinal Endoscopy (Modified Los Angeles Classification: Grade N) | E3810 20 mg | 77.0 | Percentage of Participants |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | E3810 20 mg Once Daily | 113 | |
| Overall Study | STARTED | E3810 10 mg Twice Daily | 111 | |
| Overall Study | STARTED | E3810 20 mg Twice Daily | 113 | |
| Overall Study | COMPLETED | E3810 20 mg Once Daily | 102 | |
| Overall Study | COMPLETED | E3810 10 mg Twice Daily | 103 | |
| Overall Study | COMPLETED | E3810 20 mg Twice Daily | 100 | |
| Overall Study | NOT COMPLETED | E3810 20 mg Once Daily | 11 | |
| Overall Study | NOT COMPLETED | E3810 10 mg Twice Daily | 8 | |
| Overall Study | NOT COMPLETED | E3810 20 mg Twice Daily | 13 |
Source ClinicalTrials.gov
Adverse events63
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 | Nasopharyngitis | Infections and infestations | E3810 20 mg Once Daily | 8 | 112 | |
| other | Nasopharyngitis | Infections and infestations | E3810 10 mg Twice Daily | 7 | 111 | |
| other | Nasopharyngitis | Infections and infestations | E3810 20 mg | 4 | 114 | |
| other | Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | E3810 20 mg Once Daily | 4 | 112 | |
| other | Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | E3810 10 mg Twice Daily | 2 | 111 | |
| other | Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | E3810 20 mg | 2 | 114 | |
| other | Constipation | Gastrointestinal disorders | E3810 20 mg Once Daily | 2 | 112 | |
| other | Constipation | Gastrointestinal disorders | E3810 10 mg Twice Daily | 3 | 111 | |
| other | Constipation | Gastrointestinal disorders | E3810 20 mg | 5 | 114 | |
| other | Diarrhoea | Gastrointestinal disorders | E3810 20 mg Once Daily | 2 | 112 |
1 to 10 of 63Source ClinicalTrials.gov
See all 63 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | E3810 20 mg Once Daily | ||
| Total, all-cause mortality | E3810 10 mg Twice Daily | ||
| Total, all-cause mortality | E3810 20 mg | ||
| Total, other adverse events | E3810 20 mg Once Daily | 27 | 112 |
| Total, other adverse events | E3810 10 mg Twice Daily | 25 | 111 |
| Total, other adverse events | E3810 20 mg | 20 | 114 |
| Total, serious adverse events | E3810 20 mg Once Daily | 3 | 112 |
| Total, serious adverse events | E3810 10 mg Twice Daily | 6 | 111 |
| Total, serious adverse events | E3810 20 mg | 5 | 114 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT00770913
GET https://conductscience.org/api/trials/v1/NCT00770913/events?page=2