Trial · NCT00728481

The Role Of Gastroesophageal Reflux Disease (GERD) in Eosinophilic Esophagitis

NCT00728481, Phase 2, Phase 3, Completed, Mayo Clinic; results first posted 2012-12-06

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. The Role Of Gastroesophageal Reflux Disease (GERD) in Eosinophilic Esophagitis. Trials, record NCT00728481. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00728481

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: The Role Of Gastroesophageal Reflux Disease (GERD) in Eosinophilic Esophagitis
NCT number: NCT00728481
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 51 participants, actual
Lead sponsor: Mayo Clinic
Conditions: Eosinophilic Esophagitis, Gastroesophageal Reflux Disease, EE, GERD
Interventions: Esomeprazole, Budesonide
First posted: 2008-08-05
Last updated: 2016-01-14
Results first posted: 2012-12-06
Limitations and caveats: The index endoscopy was obtained solely for clinical reasons and could have been done as long as 18 months prior to study enrollment.~A single question on the dysphagia questionnaire was used to assess dysphagia symptom response.

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Histological Response to Treatment	Baseline, 6 months	Subjects with Esophageal eosinophilia experiencing a histological response to treatment. Subjects were considered to have histological response to treatment if both sets of biopsies (from the distal and mid-esophagus) had, on average, less than 5 eosinophils per high power field (eos/hpf) at the 6-month biopsies.
Primary	Symptomatic Response to Treatment	Baseline, 6 months	Subjects with Esophageal eosinophilia experiencing a response in their dysphagia symptoms to treatment. Symptomatic improvement in symptoms was defined as a score of at least two levels lower than the baseline dysphagia symptom question on the Mayo Dysphagia Questionnaire-30 days (MDQ-30). Dysphagia symptoms were determined based on the MDQ-30 question: 'How would you rate the severity of your trouble swallowing in the past 30 days' with a 5 point scale ranging from 'does not bother me at all' to 'very severe, markedly affects my lifestyle'. Patients must have marked a score of 3 or higher corresponding to 'Moderate, cannot be ignored, but does not affect my lifestyle' to be included in the study.
Secondary	Change in Dysphagia Symptoms in Subjects With Histological Response to Treatment	Baseline, 6 months	Dysphagia symptoms were determined based on the Mayo Dysphagia Questionnaire-30 days (MDQ-30), using the question: 'How would you rate the severity of your trouble swallowing in the past 30 days' with a 5 point scale ranging from 'does not bother me at all' to 'very severe, markedly affects my lifestyle'. Symptomatic improvement was defined as only an improvement of 2 levels on this question.
Secondary	Change in Dysphagia Symptoms in Subjects With Non-significant Histological Response to Treatment	Baseline, 6 months	Dysphagia symptoms were determined based on the Mayo Dysphagia Questionnaire-30 days (MDQ-30), using the question: 'How would you rate the severity of your trouble swallowing in the past 30 days' with a 5 point scale ranging from 'does not bother me at all' to 'very severe, markedly affects my lifestyle'. Patients must have marked a score of 3 or higher corresponding to 'Moderate, cannot be ignored, but does not affect my lifestyle' to be included in the study.
Secondary	Participants With Presence of Esophageal Rings/Furrows at Six Month Endoscopy	Baseline, 6 months	Multiple concentric rings or furrows of the esophagus is an endoscopic finding traditionally ascribed to eosinophilic esophagitis.
Secondary	Participants With Presence of Erosive Esophagitis at Six Month Endoscopy	Baseline, 6 months

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Histological Response to Treatment	Baseline, 6 months		Participants	NUMBER
SECONDARY	Change in Dysphagia Symptoms in Subjects With Histological Response to Treatment	Baseline, 6 months	The analysis population includes only subjects with a histologic response. Subjects were considered to have a histological response to treatment if both sets of biopsies (from distal \& mid-esophagus) had, on average, less than 5 eos/hpf.	Participants	NUMBER
SECONDARY	Change in Dysphagia Symptoms in Subjects With Non-significant Histological Response to Treatment	Baseline, 6 months	The analysis population for this item only included subjects with a non-significant histologic response. Subjects were considered to have a histological response to treatment if both sets of 6-month biopsies (from distal \& mid-esophagus) had, on average, less than 5 eos/hpf.	Participants	NUMBER
SECONDARY	Participants With Presence of Esophageal Rings/Furrows at Six Month Endoscopy	Baseline, 6 months		participants	NUMBER
SECONDARY	Participants With Presence of Erosive Esophagitis at Six Month Endoscopy	Baseline, 6 months		participants	NUMBER
PRIMARY	Symptomatic Response to Treatment	Baseline, 6 months		Participants	NUMBER

Source ClinicalTrials.gov

Results by group20

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Histological Response to Treatment	Esomeprazole	Subjects with histological response	11	Participants
Histological Response to Treatment	Budesonide	Subjects with histological response	16	Participants
Histological Response to Treatment	Esomeprazole	Subjects with nonsignificant histological response	7	Participants
Histological Response to Treatment	Budesonide	Subjects with nonsignificant histological response	12	Participants
Change in Dysphagia Symptoms in Subjects With Histological Response to Treatment	Esomeprazole	Dysphagia symptoms improved	5	Participants
Change in Dysphagia Symptoms in Subjects With Histological Response to Treatment	Budesonide	Dysphagia symptoms improved	11	Participants
Change in Dysphagia Symptoms in Subjects With Histological Response to Treatment	Esomeprazole	Dysphagia symptoms did not improve	6	Participants
Change in Dysphagia Symptoms in Subjects With Histological Response to Treatment	Budesonide	Dysphagia symptoms did not improve	5	Participants
Change in Dysphagia Symptoms in Subjects With Non-significant Histological Response to Treatment	Esomeprazole	Dysphagia symptoms responded to treatment	6	Participants
Change in Dysphagia Symptoms in Subjects With Non-significant Histological Response to Treatment	Budesonide	Dysphagia symptoms responded to treatment	4	Participants

1 to 10 of 20Source ClinicalTrials.gov

See all 20 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Esomeprazole	19
Overall Study	STARTED	Budesonide	32
Overall Study	COMPLETED	Esomeprazole	18
Overall Study	COMPLETED	Budesonide	28
Overall Study	NOT COMPLETED	Esomeprazole	1
Overall Study	NOT COMPLETED	Budesonide	4

Source ClinicalTrials.gov

Adverse events2

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	Hives	Immune system disorders	Esomeprazole	1	18	1
other	Hives	Immune system disorders	Budesonide	1	28	1

Source ClinicalTrials.gov

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	Budesonide
Total, other adverse events	Esomeprazole	1	18
Total, other adverse events	Budesonide	1	28
Total, serious adverse events	Esomeprazole	0	18
Total, serious adverse events	Budesonide	0	28

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
22111863	RESULT

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
Esomeprazole vs Budesonide: Participants With Presence of Erosive Esophagitis at Six Month Endoscopy	Trial comparisons
Esomeprazole vs Budesonide: Participants With Presence of Esophageal Rings/Furrows at Six Month Endoscopy	Trial comparisons
Esomeprazole vs Budesonide: 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT00728481

GET https://conductscience.org/api/trials/v1/NCT00728481/registered

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