Trial · NCT02605837
A Study in Adolescents and Adults With Eosinophilic Esophagitis (EoE) Measuring Histologic Response and Determine if Reduction in Dysphagia is Achieved
NCT02605837, Phase 3, Completed, Shire; results first posted 2020-03-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study in Adolescents and Adults With Eosinophilic Esophagitis (EoE) Measuring Histologic Response and Determine if Reduction in Dysphagia is Achieved. Trials, record NCT02605837. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02605837
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study in Adolescents and Adults With Eosinophilic Esophagitis (EoE) Measuring Histologic Response and Determine if Reduction in Dysphagia is Achieved
- NCT number
- NCT02605837
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 318 participants, actual
- Lead sponsor
- Shire
- Conditions
- Eosinophilic Esophagitis (EoE)
- Interventions
- Oral Budesonide Suspension (OBS), Placebo
- First posted
- 2015-11-16
- Last updated
- 2025-02-19
- Results first posted
- 2020-03-16
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Histologic Response at the Final Treatment Period Evaluation (Week 16) | Week 16 | Histologic response was defined as a peak eosinophil count of less than or equal to (\<=) 6/ high-powered field (HPF) across all available esophageal levels at final treatment period evaluation (Week 16). Histologic response after 12 weeks of double blind treatment at Week 16 was reported. |
| Primary | Number of Participants With Dysphagia Symptom Response at the Final Treatment Period Evaluation (Week 16) | Week 16 | Dysphagia symptom response was defined as greater than or equal to (\>=) 30 percent (%) reduction in the Dysphagia Symptom Questionnaire (DSQ) combined score (questions 2+3). DSQ contained 4 questions, all participants used a diary, and responded to Questions 1 (did you eat solid food) and 2 (did food pass slowly or get stuck). If the participant's answer to Question 2 was 'No', the diary ended for that day. If a participant answered 'Yes', he/she advanced to Questions 3 (did you have to do anything to make the food go down or get relief) and 4 (extent to which the participant experienced pain while swallowing). DSQ score= (\[sum of points from questions 2+3 in the daily DSQ\]×14)/ Number of diaries reported with non-missing data. Dysphagia symptom response after 12 weeks of double blind treatment at Week 16 was reported. |
| Secondary | Change From Baseline in Dysphagia Symptom Questionnaire (DSQ) Combined Score at the Final Treatment Period Evaluation (Week 16) | Baseline, Week 16 | DSQ contained 4 questions, all participants used a diary, and responded to Questions 1 (did you eat solid food) and 2 (did food pass slowly or get stuck). If the participant's answer to Question 2 was 'No', the diary ended for that day. If a participant answered 'Yes', he/she advanced to Questions 3 (did you have to do anything to make the food go down or get relief) and 4 (extent to which the participant experienced pain while swallowing). DSQ combined score= (\[sum of points from questions 2+3 in the daily DSQ\]×14)/ Number of diaries reported with non-missing data. Scale range was 0 - 2 for question 2 and 0 - 4 for question 3, with higher values representing a worse outcome. Scale range for DSQ combined score was 0 - 84, with higher values representing a worse outcome. A negative change from baseline indicates that symptoms decreased. Change from baseline in DSQ after 12 weeks of double blind treatment at Week 16 was reported. |
| Secondary | Change From Baseline in Total Endoscopy Score at the Final Treatment Period Evaluation (Week 16) | Baseline, Week 16 | Endoscopic findings with separate evaluations of the proximal and distal esophagus were recorded with respect to 5 categories: 1) exudates or plaques (grade 0-2); 2) fixed esophageal rings (grade 0-3); 3) edema (grade 0-2); 4) furrows (grade 0-2); and 5) strictures (grade 0-1). An endoscopy score for each category was calculated and summed for each anatomic location (proximal and distal). The minimum and maximum endoscopy score was 0 and 10 points respectively for each location (proximal and distal) and the total endoscopy score was the sum of the scores for the proximal and distal locations (maximum total score of 20 points respectively). The higher score indicated worse appearance. A negative change from baseline indicates that appearance improved. Endoscopic findings after 12 weeks of double blind treatment at Week 16 were reported. |
| Secondary | Number of Participants With Peak Eosinophil Count Less Than (<)15/High-Powered Field (HPF) or Less Than or Equal to (<=)1/High-Powered Field (HPF) at the Final Treatment Period Evaluation (Week 16) | Week 16 | Participant was considered as responder at Week 16 if he/she had peak eosinophil count of \<15/HPF or \<=1/HPF across all esophagus levels. Number of participants with peak eosinophil count \< 15/HPF or \<=1/HPF after 12 weeks of double blind treatment at Week 16 were reported. |
| Secondary | Change From Baseline in the Peak Eosinophil Count at the Final Treatment Period Evaluation (Week 16) | Baseline, Week 16 | Change from baseline in the peak eosinophil count after 12 weeks of double blind treatment at week 16 for each available esophageal level (proximal, mid, distal, maximum) were reported. |
| Secondary | Change From Baseline in the Histopathologic Epithelial Features Combined Total Score Ratio (TSR) at the Final Treatment Period Evaluation (Week 16) | Baseline, Week 16 | Change from baseline in histopathologic epithelial features combined total score of grade and stage ratio after 12 weeks of double blind treatment at Week 16 were reported by measuring eight histopathologic epithelial features: basal layer hyperplasia, eosinophil density, eosinophil micro-abscesses, eosinophil surface layering, dilated intercellular spaces, surface epithelial alteration, dyskeratotic epithelial cells, lamina propria fibrosis were scored on a 4-point scale (0=normal, 3=worst) for both the severity of the abnormality (grade) and the amount of tissue affected by the abnormality (stage). Thus each of the 3 levels had a minimum score of 0 and maximum possible score of 24, and a possible total grade or stage score of 72 for a maximum combined score of 144. Combined total score ratio (TSR) =(proximal TSR + mid TSR + distal TSR)/N, where N is the number of non missing sections for TSR. A negative change from baseline indicates that epithelial inflammation decreased. |
| Secondary | Number of Participants With Dysphagia Symptom Response (Binary Response) at the Final Treatment Period Evaluation (Week 16) | Week 16 | Dysphagia symptom response (binary response \[i.e, responders versus. non-responders\]) was defined as a \>=50% reduction in the DSQ combined score (questions 2+3), from baseline to the final treatment period evaluation (Week 16). DSQ contained 4 questions, all participants used a diary, and responded to Questions 1 (did you eat solid food) and 2 (did food pass slowly or get stuck). If the participant's answer to Question 2 was 'No', the diary ended for that day. If a participant answered 'Yes', he/she advanced to Questions 3 (did you have to do anything to make the food go down or get relief) and 4 (extent to which the participant experienced pain while swallowing). DSQ score= (\[sum of points from questions 2+3 in the daily DSQ\]×14)/ Number of diaries reported with non-missing data. Number of participants with binary response after 12 weeks of double blind treatment at Week 16 were reported. |
| Secondary | Number of Participants With Overall Binary Response I at the Final Treatment Period Evaluation (Week 16) | Week 16 | Overall binary response I was defined as a reduction in the DSQ score of \>=30% from baseline to the final treatment period (week 16) evaluation and a peak eosinophil count of \<=6/HPF across all esophageal levels at the final treatment period evaluation. Participant was considered as responder at Week 16 if he/she achieved a minimum of 30% reduction in DSQ combined score between baseline and Week 16 and has peak eosinophil count of \<=6/HPF across all esophagus levels. Number of participants with overall binary response I after 12 weeks of double blind treatment at Week 16 were reported. |
| Secondary | Number of Participants With Overall Binary Response II at the Final Treatment Period Evaluation (Week 16) | Week 16 | Overall binary response II was defined as a reduction in the DSQ score of \>=50% from baseline to the final treatment period evaluation and a peak eosinophil count of \<=6/HPF across all esophageal levels at the final treatment period evaluation. Participant was considered as responder at Week 16 if he/she achieved a minimum of 50% reduction in DSQ combined score between baseline and Week 16 and had peak eosinophil count of \<=6/HPF across all esophagus levels. Number of participants with overall binary response II after 12 weeks of double blind treatment at Week 16 were reported. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes20
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 Histologic Response at the Final Treatment Period Evaluation (Week 16) | Week 16 | FAS included all randomized participants who received at least one dose of a double-blind IP. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Dysphagia Symptom Response at the Final Treatment Period Evaluation (Week 16) | Week 16 | FAS included all randomized participants who received at least one dose of a double-blind IP. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Dysphagia Symptom Questionnaire (DSQ) Combined Score at the Final Treatment Period Evaluation (Week 16) | Baseline, Week 16 | FAS included all randomized participants who received at least one dose of a double-blind IP. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure. | Score on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Total Endoscopy Score at the Final Treatment Period Evaluation (Week 16) | Baseline, Week 16 | FAS included all randomized participants who received at least one dose of a double-blind IP. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure. | score on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With Peak Eosinophil Count Less Than (<)15/High-Powered Field (HPF) or Less Than or Equal to (<=)1/High-Powered Field (HPF) at the Final Treatment Period Evaluation (Week 16) | Week 16 | FAS included all randomized participants who received at least one dose of a double-blind IP. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in the Peak Eosinophil Count at the Final Treatment Period Evaluation (Week 16) | Baseline, Week 16 | FAS included all randomized participants who received at least one dose of a double-blind IP. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure at each specific category. | eosinophil count | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in the Histopathologic Epithelial Features Combined Total Score Ratio (TSR) at the Final Treatment Period Evaluation (Week 16) | Baseline, Week 16 | FAS included all randomized participants who received at least one dose of a double-blind IP. Here the number of participants analyzed signifies participants who were evaluable for this outcome measure. | score on scale | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With Dysphagia Symptom Response (Binary Response) at the Final Treatment Period Evaluation (Week 16) | Week 16 | FAS included all randomized participants who received at least one dose of a double-blind IP. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Overall Binary Response I at the Final Treatment Period Evaluation (Week 16) | Week 16 | FAS included all randomized participants who received at least one dose of a double-blind IP. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Overall Binary Response II at the Final Treatment Period Evaluation (Week 16) | Week 16 | FAS included all randomized participants who received at least one dose of a double-blind IP. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group57
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 Histologic Response at the Final Treatment Period Evaluation (Week 16) | Placebo | Histology Response - Yes | 1 | Participants | |
| Number of Participants With Histologic Response at the Final Treatment Period Evaluation (Week 16) | Oral Budesonide Suspension (OBS) | Histology Response - Yes | 113 | Participants | |
| Number of Participants With Histologic Response at the Final Treatment Period Evaluation (Week 16) | Placebo | Histology Response - No | 104 | Participants | |
| Number of Participants With Histologic Response at the Final Treatment Period Evaluation (Week 16) | Oral Budesonide Suspension (OBS) | Histology Response - No | 100 | Participants | |
| Number of Participants With Dysphagia Symptom Response at the Final Treatment Period Evaluation (Week 16) | Placebo | Dysphagia symptom response: Yes | 41 | Participants | |
| Number of Participants With Dysphagia Symptom Response at the Final Treatment Period Evaluation (Week 16) | Oral Budesonide Suspension (OBS) | Dysphagia symptom response: Yes | 112 | Participants | |
| Number of Participants With Dysphagia Symptom Response at the Final Treatment Period Evaluation (Week 16) | Placebo | Dysphagia symptom response: No | 64 | Participants | |
| Number of Participants With Dysphagia Symptom Response at the Final Treatment Period Evaluation (Week 16) | Oral Budesonide Suspension (OBS) | Dysphagia symptom response: No | 101 | Participants | |
| Change From Baseline in Dysphagia Symptom Questionnaire (DSQ) Combined Score at the Final Treatment Period Evaluation (Week 16) | Placebo | -9.07 | Standard Error 1.519 | Score on scale | |
| Change From Baseline in Dysphagia Symptom Questionnaire (DSQ) Combined Score at the Final Treatment Period Evaluation (Week 16) | Oral Budesonide Suspension (OBS) | -12.99 | Standard Error 1.202 | Score on scale |
1 to 10 of 57Source ClinicalTrials.gov
See all 57 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 105 | |
| Overall Study | STARTED | Oral Budesonide Suspension (OBS) | 213 | |
| Overall Study | COMPLETED | Placebo | 94 | |
| Overall Study | COMPLETED | Oral Budesonide Suspension (OBS) | 202 | |
| Overall Study | NOT COMPLETED | Placebo | 11 | |
| Overall Study | NOT COMPLETED | Oral Budesonide Suspension (OBS) | 11 |
Source ClinicalTrials.gov
Adverse events46
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 | Placebo | 5 | 105 | 5 |
| other | Diarrhoea | Gastrointestinal disorders | Oral Budesonide Suspension (OBS) | 2 | 213 | 2 |
| other | Nausea | Gastrointestinal disorders | Placebo | 3 | 105 | 3 |
| other | Nausea | Gastrointestinal disorders | Oral Budesonide Suspension (OBS) | 6 | 213 | 6 |
| other | Oesophagitis | Gastrointestinal disorders | Placebo | 0 | 105 | 0 |
| other | Oesophagitis | Gastrointestinal disorders | Oral Budesonide Suspension (OBS) | 5 | 213 | 5 |
| other | Vomiting | Gastrointestinal disorders | Placebo | 4 | 105 | 6 |
| other | Vomiting | Gastrointestinal disorders | Oral Budesonide Suspension (OBS) | 4 | 213 | 4 |
| other | Nasopharyngitis | Infections and infestations | Placebo | 4 | 105 | 6 |
| other | Nasopharyngitis | Infections and infestations | Oral Budesonide Suspension (OBS) | 11 | 213 | 13 |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 105 |
| Total, all-cause mortality | Oral Budesonide Suspension (OBS) | 0 | 213 |
| Total, other adverse events | Placebo | 28 | 105 |
| Total, other adverse events | Oral Budesonide Suspension (OBS) | 63 | 213 |
| Total, serious adverse events | Placebo | 1 | 105 |
| Total, serious adverse events | Oral Budesonide Suspension (OBS) | 2 | 213 |
Source ClinicalTrials.gov
Papers6
The papers the trial lists on ClinicalTrials.gov.
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 Budesonide Suspension (OBS) vs Placebo: deaths from any cause | Trial comparisons |
| Oral Budesonide Suspension (OBS) vs Placebo: Number of Participants With Treatment-Emergent Adverse Events (AE) | Trial comparisons |
| Oral Budesonide Suspension (OBS) vs Placebo: 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/NCT02605837
GET https://conductscience.org/api/trials/v1/NCT02605837/results?page=2