Trial · NCT00895817
Fluticasone Versus Esomeprazole to Treat Eosinophilic Esophagitis
NCT00895817, Not applicable, Completed, Walter Reed Army Medical Center; results first posted 2013-03-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Fluticasone Versus Esomeprazole to Treat Eosinophilic Esophagitis. Trials, record NCT00895817. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00895817
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Fluticasone Versus Esomeprazole to Treat Eosinophilic Esophagitis
- NCT number
- NCT00895817
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 42 participants, actual
- Lead sponsor
- Walter Reed Army Medical Center
- Conditions
- Eosinophilic Esophagitis
- Interventions
- Swallowed fluticasone, Esomeprazole
- First posted
- 2009-05-08
- Last updated
- 2013-03-12
- Results first posted
- 2013-03-12
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Who Responded | 8 weeks | Histologic resolution of esophageal eosinophilia. Response is defined as achieving \< 7 eosinophils/high power field in both the proximal and distal esophagus. |
| Secondary | Symptom Score | 8 weeks | Using a validated questionnaire, symptoms will be assessed at baseline and following therapy. |
| Secondary | Endoscopic Change | 8 weeks | Following therapy, resolution of EE findings will be assessed. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Who Responded | 8 weeks | Sample size estimation was based on the assumptions:10% of the EE patients will respond to PPI compared to 55% of patients treated with steroids. Controlling the probability of a Type I error at alpha=0.05, a sample of 38 patients in the treatment groups (19 in each arm) will have 80% power to detect a difference in treatment response of 45%. | participants | NUMBER |
| SECONDARY | Symptom Score | 8 weeks | |||
| SECONDARY | Endoscopic Change | 8 weeks |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Who Responded | Esomeprazole | 7 | participants | ||
| Number of Participants Who Responded | Swallowed Fluticasone | 4 | participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Esomeprazole | 21 | |
| Overall Study | STARTED | Swallowed Fluticasone | 21 | |
| Overall Study | COMPLETED | Esomeprazole | 21 | |
| Overall Study | COMPLETED | Swallowed Fluticasone | 21 | |
| Overall Study | NOT COMPLETED | Esomeprazole | 0 | |
| Overall Study | NOT COMPLETED | Swallowed Fluticasone | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Esomeprazole | ||
| Total, all-cause mortality | Swallowed Fluticasone | ||
| Total, other adverse events | Esomeprazole | 0 | 21 |
| Total, other adverse events | Swallowed Fluticasone | 0 | 21 |
| Total, serious adverse events | Esomeprazole | 0 | 21 |
| Total, serious adverse events | Swallowed Fluticasone | 0 | 21 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Esomeprazole vs Swallowed Fluticasone: Number of Participants Who Responded | Trial comparisons |
| Esomeprazole vs Swallowed Fluticasone: serious adverse events | 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/NCT00895817
GET https://conductscience.org/api/trials/v1/NCT00895817/registered