Trial Outcomes & Findings for Eosinophilic Esophagitis Clinical Therapy Comparison Trial (NCT NCT01821898)
NCT ID: NCT01821898
Last Updated: 2021-01-11
Results Overview
The primary outcome will be the peak eosinophil/high powered field on repeat biopsy after the treatment phase.
TERMINATED
PHASE2
3 participants
16 weeks
2021-01-11
Participant Flow
Participant milestones
| Measure |
Positive for Food Allergy: Group A
Oral Budesonide
Oral Budesonide: This group will receive oral viscous budesonide at a dose of 1 or 2 mg depending on the height divided twice a day. Children \< 10 years will receive 1 mg daily. Children 10 years and older will receive 2 mg daily.
|
Positive for Food Allergy: Group B
Elimination diet
Elimination diet: This group will receive an elimination diet
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
1
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Positive for Food Allergy: Group A
Oral Budesonide
Oral Budesonide: This group will receive oral viscous budesonide at a dose of 1 or 2 mg depending on the height divided twice a day. Children \< 10 years will receive 1 mg daily. Children 10 years and older will receive 2 mg daily.
|
Positive for Food Allergy: Group B
Elimination diet
Elimination diet: This group will receive an elimination diet
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
Baseline Characteristics
Eosinophilic Esophagitis Clinical Therapy Comparison Trial
Baseline characteristics by cohort
| Measure |
Positive for Food Allergy: Group A
n=2 Participants
Oral Budesonide
Oral Budesonide: This group will receive oral viscous budesonide at a dose of 1 or 2 mg depending on the height divided twice a day.
|
Positive for Food Allergy: Group B
n=1 Participants
Elimination diet
Elimination diet: This group will receive an elimination diet
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
EoE endoscopy score
Patient 1
|
18 cells/high powered field
n=5 Participants
|
0 cells/high powered field
n=7 Participants
|
18 cells/high powered field
n=5 Participants
|
|
EoE endoscopy score
Patient 2
|
0 cells/high powered field
n=5 Participants
|
21 cells/high powered field
n=7 Participants
|
21 cells/high powered field
n=5 Participants
|
|
EoE endoscopy score
Patient 3
|
30 cells/high powered field
n=5 Participants
|
0 cells/high powered field
n=7 Participants
|
30 cells/high powered field
n=5 Participants
|
PRIMARY outcome
Timeframe: 16 weeksPopulation: None of the enrolled participants had a repeat biopsy because they did not finish the trial due to undue stress and anxiety.
The primary outcome will be the peak eosinophil/high powered field on repeat biopsy after the treatment phase.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 16 weeksPopulation: None of the enrolled participants had a PedQL because they did not finish the trial due to undue stress and anxiety.
PedsQL total survey score to assess overall quality of life before and after treatment
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 16 weeksPopulation: Pediatric Eosinophilic Esophagitis (EoE) Symptom Severity Module was not completed because the subjects did not finish the trial due to undue stress and anxiety.
Assess the subject's symptoms using the validated tool termed Pediatric Eosinophilic Esophagitis (EoE) Symptom Severity Module by measuring % of normal bolus transit swallow and % of normal peristaltic esophageal body contractions.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Conclusion of studyPopulation: Analysis was not performed.
Proteomic studies search for certain proteins in the blood that may be linked to active EoE. Immune analysis will help identify better methods for diagnosis, treatment, and prevention of immune system changes leading to diseases.
Outcome measures
Outcome data not reported
Adverse Events
Positive for Food Allergy: Group A
Positive for Food Allergy: Group B
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Carla M. Davis, MD
Baylor College of Medicine/Texas Children's Hospital
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place