Trial · NCT00634114
Reflux Esophagitis Phase III Study (Maintenance Treatment)
NCT00634114, Phase 3, Completed, AstraZeneca; results first posted 2010-06-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Reflux Esophagitis Phase III Study (Maintenance Treatment). Trials, record NCT00634114. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00634114
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Reflux Esophagitis Phase III Study (Maintenance Treatment)
- NCT number
- NCT00634114
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 540 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Reflux Esophagitis
- Interventions
- Esomeprazole, Esomeprazole, Omeprazole
- First posted
- 2008-03-12
- Last updated
- 2010-06-17
- Results first posted
- 2010-06-17
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification Throughout the Treatment Period. | Up to 24 weeks | Los Angels classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C and Grade D). A patient classfied into Grade O was considered no reflux esophagitis. The participants who had a healing of reflux esophagitis with Grade O at Visit 1 were randomised. Number of participants who did not have Grades A-D throughout the treatment period was evaluated. |
| Secondary | Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification up to 4 Weeks After Treatment | up to 4 weeks | Los Angels classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C and Grade D). A patient classfied into Grade O was considered no reflux esophagitis. The participants who had a healing of reflux esophagitis with Grade O at Visit 1 were randomised. Number of participants who did not have Grades A-D up to 4 weeks after treatment was evaluated. |
| Secondary | Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification up to 12 Weeks After Treatment | Up to 12 weeks | Los Angels classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C and Grade D). A patient classfied into Grade O was considered no reflux esophagitis. The participants who had a healing of reflux esophagitis with Grade O at Visit 1 were randomised. Number of participants who did not have Grades A-D up to 12 weeks after treatment was evaluated. |
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 | Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification up to 4 Weeks After Treatment | up to 4 weeks | Participants | NUMBER | |
| PRIMARY | Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification Throughout the Treatment Period. | Up to 24 weeks | Participants | NUMBER | |
| SECONDARY | Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification up to 12 Weeks After Treatment | Up to 12 weeks | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification up to 4 Weeks After Treatment | Experimental: Esomeprazole 20 mg | 184 | Participants | ||
| Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification up to 4 Weeks After Treatment | Experimental: Esomeprazole 10 mg | 180 | Participants | ||
| Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification up to 4 Weeks After Treatment | Comparator: Omeprazole 10 mg | 171 | Participants | ||
| Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification Throughout the Treatment Period. | Experimental: Esomeprazole 20 mg | 174 | Participants | ||
| Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification Throughout the Treatment Period. | Experimental: Esomeprazole 10 mg | 166 | Participants | ||
| Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification Throughout the Treatment Period. | Comparator: Omeprazole 10 mg | 156 | Participants | ||
| Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification up to 12 Weeks After Treatment | Experimental: Esomeprazole 20 mg | 179 | NA to NA | Participants | |
| Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification up to 12 Weeks After Treatment | Experimental: Esomeprazole 10 mg | 172 | NA to NA | Participants | |
| Absence of Recurrence of Reflux Esophagitis According to Los Angeles Classification up to 12 Weeks After Treatment | Comparator: Omeprazole 10 mg | 163 | NA to NA | 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 | Experimental: Esomeprazole 20 mg | 188 | |
| Overall Study | STARTED | Experimental: Esomeprazole 10 mg | 189 | |
| Overall Study | STARTED | Comparator: Omeprazole 10 mg | 187 | |
| Overall Study | COMPLETED | Experimental: Esomeprazole 20 mg | 160 | |
| Overall Study | COMPLETED | Experimental: Esomeprazole 10 mg | 154 | |
| Overall Study | COMPLETED | Comparator: Omeprazole 10 mg | 148 | |
| Overall Study | NOT COMPLETED | Experimental: Esomeprazole 20 mg | 28 | |
| Overall Study | NOT COMPLETED | Experimental: Esomeprazole 10 mg | 35 | |
| Overall Study | NOT COMPLETED | Comparator: Omeprazole 10 mg | 39 |
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 | Experimental: Esomeprazole 20 mg | 31 | 188 | |
| other | Nasopharyngitis | Infections and infestations | Experimental: Esomeprazole 10 mg | 37 | 188 | |
| other | Nasopharyngitis | Infections and infestations | Comparator: Omeprazole 10 mg | 31 | 187 | |
| other | Upper respiratory tract infection | Infections and infestations | Experimental: Esomeprazole 20 mg | 4 | 188 | |
| other | Upper respiratory tract infection | Infections and infestations | Experimental: Esomeprazole 10 mg | 1 | 188 | |
| other | Upper respiratory tract infection | Infections and infestations | Comparator: Omeprazole 10 mg | 0 | 187 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Experimental: Esomeprazole 20 mg | 11 | 188 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Experimental: Esomeprazole 10 mg | 3 | 188 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Comparator: Omeprazole 10 mg | 4 | 187 | |
| other | Diarrhoea | Gastrointestinal disorders | Experimental: Esomeprazole 20 mg | 4 | 188 |
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 | Experimental: Esomeprazole 20 mg | ||
| Total, all-cause mortality | Experimental: Esomeprazole 10 mg | ||
| Total, all-cause mortality | Comparator: Omeprazole 10 mg | ||
| Total, other adverse events | Experimental: Esomeprazole 20 mg | 71 | 188 |
| Total, other adverse events | Experimental: Esomeprazole 10 mg | 69 | 188 |
| Total, other adverse events | Comparator: Omeprazole 10 mg | 34 | 187 |
| Total, serious adverse events | Experimental: Esomeprazole 20 mg | 5 | 188 |
| Total, serious adverse events | Experimental: Esomeprazole 10 mg | 4 | 188 |
| Total, serious adverse events | Comparator: Omeprazole 10 mg | 1 | 187 |
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/NCT00634114
GET https://conductscience.org/api/trials/v1/NCT00634114/events?page=2