Trial · NCT02371941
Oral Cromolyn Sodium for the Treatment of Eosinophilic Esophagitis
NCT02371941, Phase 4, Completed, University of Tennessee; results first posted 2023-10-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Oral Cromolyn Sodium for the Treatment of Eosinophilic Esophagitis. Trials, record NCT02371941. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02371941
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Oral Cromolyn Sodium for the Treatment of Eosinophilic Esophagitis
- NCT number
- NCT02371941
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 16 participants, actual
- Lead sponsor
- University of Tennessee
- Conditions
- Eosinophilic Esophagitis
- Interventions
- oral cromolyn sodium, Placebo
- First posted
- 2015-02-26
- Last updated
- 2023-10-26
- Results first posted
- 2023-10-26
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Peak Esophageal Eosinophil Count | 2 months | Measure of the peak esophageal eosinophil count on esophageal biopsy specimens after 2 months of therapy |
| Secondary | Symptoms as Measured by Pediatric Eosinophilic Esophagitis Symptom Score | Baseline as compared to 2 months | Symptom scores will be measures at baseline, 1 month, and 2 months using a symptom scoring assessment tool known as the Pediatric Eosinophilic Esophagitis Symptom Score (PEESS). The PEESS is a validated symptom score that is completed by the parent of the patient. It encompasses frequency and severity of EoE related symptoms over the past month. The minimum score = 0. The max score = 98 The higher the score/value, the more severe and/or frequent the symptoms and therefore a worse outcome. |
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 | Peak Esophageal Eosinophil Count | 2 months | Peak # of eosinophils counted per field | MEDIAN | |
| SECONDARY | Symptoms as Measured by Pediatric Eosinophilic Esophagitis Symptom Score | Baseline as compared to 2 months | units on a scale | MEAN |
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 |
|---|---|---|---|---|---|
| Peak Esophageal Eosinophil Count | Oral Cromolyn | 57.3 | Standard Deviation 44.02 | Peak # of eosinophils counted per field | |
| Peak Esophageal Eosinophil Count | Placebo | 71.3 | Standard Deviation 52.7 | Peak # of eosinophils counted per field | |
| Symptoms as Measured by Pediatric Eosinophilic Esophagitis Symptom Score | Oral Cromolyn | Baseline PEES score | 37.89 | Standard Deviation 12.2 | units on a scale |
| Symptoms as Measured by Pediatric Eosinophilic Esophagitis Symptom Score | Placebo | Baseline PEES score | 30.3 | Standard Deviation 13.7 | units on a scale |
| Symptoms as Measured by Pediatric Eosinophilic Esophagitis Symptom Score | Oral Cromolyn | 2 month PEES score | 17.5 | Standard Deviation 12.8 | units on a scale |
| Symptoms as Measured by Pediatric Eosinophilic Esophagitis Symptom Score | Placebo | 2 month PEES score | 22.3 | Standard Deviation 19.1 | 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 Cromolyn | 9 | |
| Overall Study | STARTED | Placebo | 7 | |
| Overall Study | COMPLETED | Oral Cromolyn | 9 | |
| Overall Study | COMPLETED | Placebo | 6 | |
| Overall Study | NOT COMPLETED | Oral Cromolyn | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 1 |
Source ClinicalTrials.gov
Adverse events6
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 | nausea | Gastrointestinal disorders | Oral Cromolyn | 5 | 9 | 5 |
| other | nausea | Gastrointestinal disorders | Placebo | 1 | 7 | 1 |
| other | abdominal pain | Gastrointestinal disorders | Oral Cromolyn | 4 | 9 | 4 |
| other | abdominal pain | Gastrointestinal disorders | Placebo | 2 | 7 | 2 |
| other | headache | Nervous system disorders | Oral Cromolyn | 4 | 9 | 4 |
| other | headache | Nervous system disorders | Placebo | 1 | 7 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Oral Cromolyn | 0 | 9 |
| Total, all-cause mortality | Placebo | 0 | 7 |
| Total, other adverse events | Oral Cromolyn | 8 | 9 |
| Total, other adverse events | Placebo | 4 | 7 |
| Total, serious adverse events | Oral Cromolyn | 0 | 9 |
| Total, serious adverse events | Placebo | 0 | 7 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 29544738 | 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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Oral Cromolyn vs Placebo: deaths from any cause | Trial comparisons |
| Oral Cromolyn 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/NCT02371941
GET https://conductscience.org/api/trials/v1/NCT02371941/registered