Trial · NCT00658632
Rabeprazole Extended-Release 50 mg Versus Esomeprazole 40 mg for Healing and Symptomatic Relief of Mild to Moderate Erosive Gastroesophageal Reflux Disease (GERD)
NCT00658632, Phase 3, Completed, Eisai Inc.; results first posted 2015-06-23
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Rabeprazole Extended-Release 50 mg Versus Esomeprazole 40 mg for Healing and Symptomatic Relief of Mild to Moderate Erosive Gastroesophageal Reflux Disease (GERD). Trials, record NCT00658632. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00658632
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Rabeprazole Extended-Release 50 mg Versus Esomeprazole 40 mg for Healing and Symptomatic Relief of Mild to Moderate Erosive Gastroesophageal Reflux Disease (GERD)
- NCT number
- NCT00658632
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,397 participants, actual
- Lead sponsor
- Eisai Inc.
- Conditions
- Gastroesophageal Reflux Disease (GERD)
- Interventions
- Rabeprazole sodium, Esomeprazole
- First posted
- 2008-04-15
- Last updated
- 2016-05-04
- Results first posted
- 2015-06-23
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Erosive Gastroesophageal Reflux Disease (eGERD) Who Achieved Endoscopically-confirmed Healing by 8 Weeks | Baseline and Week 8 | Healing at Week 4 or 8 were based on improvement of eGERD of the Los Angeles (LA) classification of esophagitis Grade A or B from Baseline. Classifications include: Not Present: No breaks (erosions) in the esophageal mucosa (however, edema, erythema, or friability may be present). Grade A: One or more mucosal breaks not more than 5mm in maximum length. Grade B: One or more mucosal breaks more than 5mm in maximum length, but not continuous between the tops of 2 mucosal folds. Grade C: Mucosal breaks continuous between the tops of 2 or more mucosal folds, but involving less than 75% of the esophageal circumference. Gread D: Mucosal breaks involving at least 75% of the esophageal circumference. |
| Primary | Percentage of Participants With eGERD Who Achieved Endoscopically-confirmed Healing by 4 Weeks | Baseline and Week 4 | Healing at Week 4 or 8 were based on improvement of eGERD of the LA classification of esophagitis Grade A or B from Baseline. Classifications include: Not Present: No breaks (erosions) in the esophageal mucosa (however, edema, erythema, or friability may be present). Grade A: One or more mucosal breaks not more than 5mm in maximum length. Grade B: One or more mucosal breaks more than 5mm in maximum length, but not continuous between the tops of 2 mucosal folds. Grade C: Mucosal breaks continuous between the tops of 2 or more mucosal folds, but involving less than 75% of the esophageal circumference. Gread D: Mucosal breaks involving at least 75% of the esophageal circumference. |
| Secondary | Percentage of Participants Who Achieved Diary-recorded Sustained Resolution of Heartburn by Week 4 | Week 4 | During the first 4 weeks of the Double-blind Phase, participants were to record heartburn in a daily diary. Participant daily symptoms for the assessment of heartburn was based on a commonly used 4-point Likert scale of none, mild, moderate and severe. A participant was considered achieving sustained resolution of heartburn if the participant had maintained at least 7 consecutive heartburn-free days. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Percentage of Participants Who Achieved Diary-recorded Sustained Resolution of Heartburn by Week 4 | Week 4 | The analysis was performed using the ITT population, defined as all randomized subjects who received at least 1 dose of study drug, minus two participants from one site who were excluded from the ITT Population per an agreement with the FDA due to concerns of possible misconduct. | Percentage of Participants | NUMBER |
| PRIMARY | Percentage of Participants With Erosive Gastroesophageal Reflux Disease (eGERD) Who Achieved Endoscopically-confirmed Healing by 8 Weeks | Baseline and Week 8 | The analysis was performed using the Intent-to-Treat (ITT) population, defined as all randomized subjects who received at least 1 dose of study drug, minus two participants from one site who were excluded from the ITT Population per an agreement with the FDA due to concerns of possible misconduct. | Percentage of Participants | NUMBER |
| PRIMARY | Percentage of Participants With eGERD Who Achieved Endoscopically-confirmed Healing by 4 Weeks | Baseline and Week 4 | The analysis was performed using the ITT population, defined as all randomized subjects who received at least 1 dose of study drug, minus two participants from one site who were excluded from the ITT Population per an agreement with the FDA due to concerns of possible misconduct. | Percentage of Participants | NUMBER |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Who Achieved Diary-recorded Sustained Resolution of Heartburn by Week 4 | ESO 40 mg | Yes | 38.5 | Percentage of Participants | |
| Percentage of Participants Who Achieved Diary-recorded Sustained Resolution of Heartburn by Week 4 | RAB ER 50 mg | Yes | 41.9 | Percentage of Participants | |
| Percentage of Participants Who Achieved Diary-recorded Sustained Resolution of Heartburn by Week 4 | ESO 40 mg | No | 50.8 | Percentage of Participants | |
| Percentage of Participants Who Achieved Diary-recorded Sustained Resolution of Heartburn by Week 4 | RAB ER 50 mg | No | 47.1 | Percentage of Participants | |
| Percentage of Participants Who Achieved Diary-recorded Sustained Resolution of Heartburn by Week 4 | ESO 40 mg | Missing | 10.7 | Percentage of Participants | |
| Percentage of Participants Who Achieved Diary-recorded Sustained Resolution of Heartburn by Week 4 | RAB ER 50 mg | Missing | 11 | Percentage of Participants | |
| Percentage of Participants With Erosive Gastroesophageal Reflux Disease (eGERD) Who Achieved Endoscopically-confirmed Healing by 8 Weeks | ESO 40 mg | Yes | 87.8 | Percentage of Participants | |
| Percentage of Participants With Erosive Gastroesophageal Reflux Disease (eGERD) Who Achieved Endoscopically-confirmed Healing by 8 Weeks | RAB ER 50 mg | Yes | 88.2 | Percentage of Participants | |
| Percentage of Participants With Erosive Gastroesophageal Reflux Disease (eGERD) Who Achieved Endoscopically-confirmed Healing by 8 Weeks | ESO 40 mg | No | 6.3 | Percentage of Participants | |
| Percentage of Participants With Erosive Gastroesophageal Reflux Disease (eGERD) Who Achieved Endoscopically-confirmed Healing by 8 Weeks | RAB ER 50 mg | No | 5.9 | Percentage of Participants |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Esomeprazole (ESO) 40 mg | 682 | |
| Overall Study | STARTED | Rabeprazole (RAB) Extended Release (ER) 50 mg | 698 | |
| Overall Study | COMPLETED | Esomeprazole (ESO) 40 mg | 618 | |
| Overall Study | COMPLETED | Rabeprazole (RAB) Extended Release (ER) 50 mg | 633 | |
| Overall Study | NOT COMPLETED | Esomeprazole (ESO) 40 mg | 64 | |
| Overall Study | NOT COMPLETED | Rabeprazole (RAB) Extended Release (ER) 50 mg | 65 |
Source ClinicalTrials.gov
Adverse events24
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 |
|---|---|---|---|---|---|---|
| serious | Acute coronary syndrome | Cardiac disorders | ESO 40 mg | 0 | 676 | |
| serious | Acute coronary syndrome | Cardiac disorders | RAB ER 50 mg | 1 | 685 | |
| serious | Acute myocardial infarction | Cardiac disorders | ESO 40 mg | 1 | 676 | |
| serious | Acute myocardial infarction | Cardiac disorders | RAB ER 50 mg | 0 | 685 | |
| serious | Crohn's disease | Gastrointestinal disorders | ESO 40 mg | 0 | 676 | |
| serious | Crohn's disease | Gastrointestinal disorders | RAB ER 50 mg | 1 | 685 | |
| serious | Gastroenteritis | Infections and infestations | ESO 40 mg | 1 | 676 | |
| serious | Gastroenteritis | Infections and infestations | RAB ER 50 mg | 1 | 685 | |
| serious | Osteoarthritis | Musculoskeletal and connective tissue disorders | ESO 40 mg | 1 | 676 | |
| serious | Osteoarthritis | Musculoskeletal and connective tissue disorders | RAB ER 50 mg | 0 | 685 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ESO 40 mg | ||
| Total, all-cause mortality | RAB ER 50 mg | ||
| Total, other adverse events | ESO 40 mg | 0 | 676 |
| Total, other adverse events | RAB ER 50 mg | 0 | 685 |
| Total, serious adverse events | ESO 40 mg | 6 | 676 |
| Total, serious adverse events | RAB ER 50 mg | 3 | 685 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| ESO 40 mg vs RAB ER 50 mg: serious adverse events |
Source Trial comparisons
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/NCT00658632
GET https://conductscience.org/api/trials/v1/NCT00658632/events?page=2