Trial · NCT00633932
Reflux Esophagitis Phase III Study (Initial Treatment)
NCT00633932, Phase 3, Completed, AstraZeneca; results first posted 2010-04-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Reflux Esophagitis Phase III Study (Initial Treatment). Trials, record NCT00633932. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00633932
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Reflux Esophagitis Phase III Study (Initial Treatment)
- NCT number
- NCT00633932
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 602 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Reflux Esophagitis
- Interventions
- Esomeprazole, Esomeprazole, Omeprazole
- First posted
- 2008-03-12
- Last updated
- 2010-12-20
- Results first posted
- 2010-04-08
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Healing of Reflux Esophagitis (RE) Who Were Graded "O" at Week 8 Out of Patients Who Were Graded "A, B, C or D" at Baseline According to Los Angeles Classification". | 8 weeks | Los Angeles classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C, Grade D). The subjects who were definitely diagnosed to have RE classified into LA classification Grade A, B, C or D based on the EGD on Visit 1 were randomised. A subject classified into LA classification Grade O was considered no reflux esophagitis. The definitions of each grade are: Grade A (Mucosal break \< 5 mm in length), Grade B (Mucosal break \> 5mm), Grade C (Mucosal break continuous between \> 2 mucosal folds) and Grade D (Mucosal break \>75% of esophageal circumference). |
| Secondary | Number of Participants With Healing of Reflux Esophagitis (RE) Who Were Graded "O" at Week 4 Out of Patients Who Were Graded "A, B, C or D" at Baseline According to Los Angeles Classification | 4 weeks | Los Angeles classification consists of 5 grades (Grade O, Grade A, Grade B, Grade C and Grade D). The subjects who were definitely diagnosed to have RE classified into LA classification Grade A, B, C or D based on the EGD on Visit 1 were randomised. A subject classified into LA classification Grade O was considered no reflux esophagitis. The definitions of each grade are: Grade A (Mucosal break \< 5 mm in length), Grade B (Mucosal break \> 5mm), Grade C (Mucosal break continuous between \> 2 mucosal folds) and Grade D (Mucosal break \>75% of esophageal circumference). |
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 | Number of Participants With Healing of Reflux Esophagitis (RE) Who Were Graded O at Week 8 Out of Patients Who Were Graded A, B, C or D at Baseline According to Los Angeles Classification. | 8 weeks | One participant for each treatment group did not take any investigational product. These 3 participants were excluded (1 for each treatment group) from all the efficacy and safety analyses. | participants | NUMBER |
| SECONDARY | Number of Participants With Healing of Reflux Esophagitis (RE) Who Were Graded O at Week 4 Out of Patients Who Were Graded A, B, C or D at Baseline According to Los Angeles Classification | 4 weeks | One participant for each treatment group did not take any investigational product. These 3 participants were excluded (1 for each treatment group) from all the efficacy and safety analyses. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Healing of Reflux Esophagitis (RE) Who Were Graded O at Week 8 Out of Patients Who Were Graded A, B, C or D at Baseline According to Los Angeles Classification. | Experimental: Esomeprazole 40mg | 171 | participants | ||
| Number of Participants With Healing of Reflux Esophagitis (RE) Who Were Graded O at Week 8 Out of Patients Who Were Graded A, B, C or D at Baseline According to Los Angeles Classification. | Experimental: Esomeprazole 20mg | 165 | participants | ||
| Number of Participants With Healing of Reflux Esophagitis (RE) Who Were Graded O at Week 8 Out of Patients Who Were Graded A, B, C or D at Baseline According to Los Angeles Classification. | Comparator: Omeprazole 20mg | 166 | participants | ||
| Number of Participants With Healing of Reflux Esophagitis (RE) Who Were Graded O at Week 4 Out of Patients Who Were Graded A, B, C or D at Baseline According to Los Angeles Classification | Experimental: Esomeprazole 40mg | 141 | participants | ||
| Number of Participants With Healing of Reflux Esophagitis (RE) Who Were Graded O at Week 4 Out of Patients Who Were Graded A, B, C or D at Baseline According to Los Angeles Classification | Experimental: Esomeprazole 20mg | 147 | participants | ||
| Number of Participants With Healing of Reflux Esophagitis (RE) Who Were Graded O at Week 4 Out of Patients Who Were Graded A, B, C or D at Baseline According to Los Angeles Classification | Comparator: Omeprazole 20mg | 143 | 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 40mg | 191 | |
| Overall Study | STARTED | Experimental: Esomeprazole 20mg | 190 | |
| Overall Study | STARTED | Comparator: Omeprazole 20mg | 191 | |
| Overall Study | COMPLETED | Experimental: Esomeprazole 40mg | 179 | |
| Overall Study | COMPLETED | Experimental: Esomeprazole 20mg | 176 | |
| Overall Study | COMPLETED | Comparator: Omeprazole 20mg | 180 | |
| Overall Study | NOT COMPLETED | Experimental: Esomeprazole 40mg | 12 | |
| Overall Study | NOT COMPLETED | Experimental: Esomeprazole 20mg | 14 | |
| Overall Study | NOT COMPLETED | Comparator: Omeprazole 20mg | 11 |
Source ClinicalTrials.gov
Adverse events15
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 | Experimental: Esomeprazole 40mg | 2 | 190 | |
| other | Diarrhoea | Gastrointestinal disorders | Experimental: Esomeprazole 20mg | 3 | 189 | |
| other | Diarrhoea | Gastrointestinal disorders | Comparator: Omeprazole 20mg | 6 | 190 | |
| other | Nasopharyngitis | Infections and infestations | Experimental: Esomeprazole 40mg | 10 | 190 | |
| other | Nasopharyngitis | Infections and infestations | Experimental: Esomeprazole 20mg | 6 | 189 | |
| other | Nasopharyngitis | Infections and infestations | Comparator: Omeprazole 20mg | 10 | 190 | |
| serious | Bronchopneumonia | Infections and infestations | Experimental: Esomeprazole 40mg | 0 | 190 | |
| serious | Bronchopneumonia | Infections and infestations | Experimental: Esomeprazole 20mg | 1 | 189 | |
| serious | Bronchopneumonia | Infections and infestations | Comparator: Omeprazole 20mg | 0 | 190 | |
| serious | Gastroenteritis | Infections and infestations | Experimental: Esomeprazole 40mg | 0 | 190 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Experimental: Esomeprazole 40mg | ||
| Total, all-cause mortality | Experimental: Esomeprazole 20mg | ||
| Total, all-cause mortality | Comparator: Omeprazole 20mg | ||
| Total, other adverse events | Experimental: Esomeprazole 40mg | 12 | 190 |
| Total, other adverse events | Experimental: Esomeprazole 20mg | 9 | 189 |
| Total, other adverse events | Comparator: Omeprazole 20mg | 16 | 190 |
| Total, serious adverse events | Experimental: Esomeprazole 40mg | 0 | 190 |
| Total, serious adverse events | Experimental: Esomeprazole 20mg | 1 | 189 |
| Total, serious adverse events | Comparator: Omeprazole 20mg | 1 | 190 |
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/NCT00633932
GET https://conductscience.org/api/trials/v1/NCT00633932/registered