Trial · NCT00638456
Use of Topical Budesonide in the Treatment of Eosinophilic Esophagitis
NCT00638456, Phase 2, Completed, Ranjan Dohil; results first posted 2019-08-14
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Use of Topical Budesonide in the Treatment of Eosinophilic Esophagitis. Trials, record NCT00638456. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00638456
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Use of Topical Budesonide in the Treatment of Eosinophilic Esophagitis
- NCT number
- NCT00638456
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 32 participants, actual
- Lead sponsor
- Ranjan Dohil
- Conditions
- Eosinophilic Esophagitis
- Interventions
- Budesonide plus Prevacid, placebo plus Prevacid
- First posted
- 2008-03-19
- Last updated
- 2019-08-14
- Results first posted
- 2019-08-14
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 With Improvement of Espohageal Eosinophilia | 3 Months | Repeat endoscopy was undertaken using the Olympus P160 endoscope (by RD) at 3 months of treatment. |
| Secondary | Upper Gastrointestinal Endoscopy Score | Baseline and 3 Months | Endoscopy scoring tool took into account the following categories: Mucosal pallor/reduced vasculature Linear furrows/mucosal thickening White plaques Concentric rings/stricture Friability/"tissue-paper" mucosa Histology scoring tools Epithelial histology score Peak eosinophil count Each category could score 0-3 for a total maximum score of 15. The higher the score the worse the disease. |
| Secondary | Symptom Score | Baseline and 3 Months | Total score was based on the following symptoms: Heartburn/regurgitation Abdominal pain Nausea/vomiting Anorexia/early satiety Dysphagia Symptom induced nocturnal wakening Gastrointestinal bleeding Each symptom could score 0-2 for a maximum score for 14 points. The lower the score the milder the symptoms and the higher the score the more severe symptoms. |
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 With Improvement of Espohageal Eosinophilia | 3 Months | 6 subjects withdrew from the oral viscous budesonide plus Prevacid group and 2 withdrew from the placebo plus Prevacid group, and so they were not included in the data analsyis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Upper Gastrointestinal Endoscopy Score | Baseline and 3 Months | units on a scale | MEAN | |
| SECONDARY | Symptom Score | Baseline and 3 Months | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group10
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 Improvement of Espohageal Eosinophilia | Oral Viscous Budesonide Plus Prevacid | 13 | Participants | ||
| Number of Participants With Improvement of Espohageal Eosinophilia | Placebo Plus Prevacid | 0 | Participants | ||
| Upper Gastrointestinal Endoscopy Score | Oral Viscous Budesonide Plus Prevacid | Baseline | 4.6 | Full Range 0 to 9 | units on a scale |
| Upper Gastrointestinal Endoscopy Score | Placebo Plus Prevacid | Baseline | 7.8 | Full Range 4 to 9 | units on a scale |
| Upper Gastrointestinal Endoscopy Score | Oral Viscous Budesonide Plus Prevacid | 3 months | 1.5 | Full Range 0 to 7 | units on a scale |
| Upper Gastrointestinal Endoscopy Score | Placebo Plus Prevacid | 3 months | 5.4 | Full Range 1 to 9 | units on a scale |
| Symptom Score | Oral Viscous Budesonide Plus Prevacid | Baseline | 3.5 | Full Range 0 to 10 | units on a scale |
| Symptom Score | Placebo Plus Prevacid | Baseline | 2.7 | Full Range 1 to 6 | units on a scale |
| Symptom Score | Oral Viscous Budesonide Plus Prevacid | 3 months | 1.2 | Full Range 0 to 7 | units on a scale |
| Symptom Score | Placebo Plus Prevacid | 3 months | 1.8 | Full Range 0 to 7 | units on a scale |
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 | Oral Viscous Budesonide Plus Prevacid | 21 | |
| Overall Study | STARTED | Placebo Plus Prevacid | 11 | |
| Overall Study | COMPLETED | Oral Viscous Budesonide Plus Prevacid | 15 | |
| Overall Study | COMPLETED | Placebo Plus Prevacid | 9 | |
| Overall Study | NOT COMPLETED | Oral Viscous Budesonide Plus Prevacid | 6 | |
| Overall Study | NOT COMPLETED | Placebo Plus Prevacid | 2 |
Source ClinicalTrials.gov
Adverse events14
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 | Emesis | Gastrointestinal disorders | Oral Viscous Budesonide Plus Prevacid | 1 | 21 | 1 |
| other | Emesis | Gastrointestinal disorders | Placebo Plus Prevacid | 0 | 11 | 0 |
| other | Oral Candida | Gastrointestinal disorders | Oral Viscous Budesonide Plus Prevacid | 1 | 21 | 1 |
| other | Oral Candida | Gastrointestinal disorders | Placebo Plus Prevacid | 0 | 11 | 0 |
| other | Trasient headache | Nervous system disorders | Oral Viscous Budesonide Plus Prevacid | 1 | 21 | 1 |
| other | Trasient headache | Nervous system disorders | Placebo Plus Prevacid | 1 | 11 | 1 |
| other | Worsening Eczema | General disorders | Oral Viscous Budesonide Plus Prevacid | 0 | 21 | 0 |
| other | Worsening Eczema | General disorders | Placebo Plus Prevacid | 1 | 11 | 1 |
| other | Chest Infection | Infections and infestations | Oral Viscous Budesonide Plus Prevacid | 0 | 21 | 0 |
| other | Chest Infection | Infections and infestations | Placebo Plus Prevacid | 1 | 11 | 1 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Oral Viscous Budesonide Plus Prevacid | 0 | 21 |
| Total, all-cause mortality | Placebo Plus Prevacid | 0 | 11 |
| Total, other adverse events | Oral Viscous Budesonide Plus Prevacid | 3 | 21 |
| Total, other adverse events | Placebo Plus Prevacid | 5 | 11 |
| Total, serious adverse events | Oral Viscous Budesonide Plus Prevacid | 0 | 21 |
| Total, serious adverse events | Placebo Plus Prevacid | 0 | 11 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 20457157 | DERIVED |
Source PubMed
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Oral Viscous Budesonide Plus Prevacid vs Placebo Plus Prevacid: Number of Participants With Improvement of Espohageal Eosinophilia | Trial comparisons |
| Oral Viscous Budesonide Plus Prevacid vs Placebo Plus Prevacid: deaths from any cause | Trial comparisons |
| Oral Viscous Budesonide Plus Prevacid vs Placebo Plus Prevacid: 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/NCT00638456
GET https://conductscience.org/api/trials/v1/NCT00638456/registered