Trial · NCT04248712
Antihistamines in Eosinophilic Esophagitis
NCT04248712, Phase 2, Terminated, Mayo Clinic; results first posted 2022-12-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Antihistamines in Eosinophilic Esophagitis. Trials, record NCT04248712. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04248712
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Antihistamines in Eosinophilic Esophagitis
- NCT number
- NCT04248712
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 1 participants, actual
- Lead sponsor
- Mayo Clinic
- Conditions
- Eosinophilic Esophagitis
- Interventions
- Famotidine, Loratadine, Placebo
- First posted
- 2020-01-30
- Last updated
- 2022-12-20
- Results first posted
- 2022-12-20
- Limitations and caveats
- Terminated study due to low enrollment. No subjects enrolled in the Placebo group
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Adverse Events | 12 weeks | Number of adverse events reported |
| Primary | Change in Maximum Eosinophil Count | 12 weeks | Calculated by maximum eosinophils per esophagogastroduodenoscopy (EGD) high-power field (eos/hpf) after therapy with antihistamines. As measured by the percentage of change in maximum eosinophil count from baseline to 12 weeks. |
| Secondary | Change in Symptoms of Eosinophilic Esophagitis, as Measured by Dysphagia Symptom Questionnaire | 12 weeks | Measured by the self-reported Dysphagia Symptom Questionnaire (DSQ). The DSQ ranges from 0 to 10, with a lower score indicating less symptoms and a higher score indicating more symptoms. |
| Secondary | Change in Endoscopic Response, as Measured by the Endoscopic Reference Score | 12 weeks | Percentage of subjects with endoscopic response as measured by the Eosinophilic Esophagitis (EoE) Endoscopic Reference Score (EREFS). The score ranges from 0 to 10, with a higher score indicating worse endoscopic findings of eosinophilic esophagitis. |
| Secondary | Change in Histologic Response | 12 weeks | Percentage of subjects with histologic response of ≤15 eos/hpf on biopsy at the lower and mid esophagus |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Adverse Events | 12 weeks | Terminated study due to low enrollment. Data collection \& analysis of Treatment group only. No subjects enrolled in the Placebo group | adverse events | NUMBER |
| PRIMARY | Change in Maximum Eosinophil Count | 12 weeks | Terminated study due to low enrollment. No subjects enrolled in the Placebo group | percentage change | NUMBER |
| SECONDARY | Change in Symptoms of Eosinophilic Esophagitis, as Measured by Dysphagia Symptom Questionnaire | 12 weeks | Terminated study due to low enrollment. Data was not collected nor analyzed. No subjects enrolled in the Placebo group | ||
| SECONDARY | Change in Endoscopic Response, as Measured by the Endoscopic Reference Score | 12 weeks | Terminated study due to low enrollment. Data was not collected nor analyzed. No subjects enrolled in the Placebo group | ||
| SECONDARY | Change in Histologic Response | 12 weeks | Terminated study due to low enrollment. Data was not collected nor analyzed. No subjects enrolled in the Placebo group |
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 |
|---|---|---|---|---|---|
| Adverse Events | Treatment Group | 0 | adverse events | ||
| Change in Maximum Eosinophil Count | Treatment Group | 0 | percentage change |
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 | Treatment Group | 1 | |
| Overall Study | STARTED | Placebo Group | 0 | |
| Overall Study | COMPLETED | Treatment Group | 1 | |
| Overall Study | COMPLETED | Placebo Group | 0 | |
| Overall Study | NOT COMPLETED | Treatment Group | 0 | |
| Overall Study | NOT COMPLETED | Placebo Group | 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 | Treatment Group | 0 | 1 |
| Total, all-cause mortality | Placebo Group | 0 | 0 |
| Total, other adverse events | Treatment Group | 0 | 1 |
| Total, other adverse events | Placebo Group | 0 | 0 |
| Total, serious adverse events | Treatment Group | 0 | 1 |
| Total, serious adverse events | Placebo Group | 0 | 0 |
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/NCT04248712
GET https://conductscience.org/api/trials/v1/NCT04248712/registered