Trial Outcomes & Findings for Use of Topical Budesonide in the Treatment of Eosinophilic Esophagitis (NCT NCT00638456)
NCT ID: NCT00638456
Last Updated: 2019-08-14
Results Overview
Repeat endoscopy was undertaken using the Olympus P160 endoscope (by RD) at 3 months of treatment.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
32 participants
Primary outcome timeframe
3 Months
Results posted on
2019-08-14
Participant Flow
Participant milestones
| Measure |
Oral Viscous Budesonide Plus Prevacid
Budesonide plus Prevacid: Budesonide is taken daily for three months. In addition, Prevacid is taken twice daily for three months.
|
Placebo Plus Prevacid
placebo plus Prevacid: Placebo is taken daily for three months. In addition, Prevacid is taken twice daily for three months.
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
11
|
|
Overall Study
COMPLETED
|
15
|
9
|
|
Overall Study
NOT COMPLETED
|
6
|
2
|
Reasons for withdrawal
| Measure |
Oral Viscous Budesonide Plus Prevacid
Budesonide plus Prevacid: Budesonide is taken daily for three months. In addition, Prevacid is taken twice daily for three months.
|
Placebo Plus Prevacid
placebo plus Prevacid: Placebo is taken daily for three months. In addition, Prevacid is taken twice daily for three months.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
6
|
2
|
Baseline Characteristics
Use of Topical Budesonide in the Treatment of Eosinophilic Esophagitis
Baseline characteristics by cohort
| Measure |
Oral Viscous Budesonide Plus Prevacid
n=21 Participants
Budesonide plus Prevacid: Budesonide is taken daily for three months. In addition, Prevacid is taken twice daily for three months.
|
Placebo Plus Prevacid
n=11 Participants
placebo plus Prevacid: Placebo is taken daily for three months. In addition, Prevacid is taken twice daily for three months.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
21 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
32 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
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 MonthsPopulation: 6 subjects withdrew from the oral viscous budesonide plus Prevacid group and 2 withdrew from the placebo plus Prevacid group, and so they were not included in the data analsyis.
Repeat endoscopy was undertaken using the Olympus P160 endoscope (by RD) at 3 months of treatment.
Outcome measures
| Measure |
Oral Viscous Budesonide Plus Prevacid
n=15 Participants
Budesonide plus Prevacid: Budesonide is taken daily for three months. In addition, Prevacid is taken twice daily for three months.
|
Placebo Plus Prevacid
n=9 Participants
placebo plus Prevacid: Placebo is taken daily for three months. In addition, Prevacid is taken twice daily for three months.
|
|---|---|---|
|
Number of Participants With Improvement of Espohageal Eosinophilia
|
13 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline and 3 MonthsEndoscopy scoring tool took into account the following categories: Mucosal pallor/reduced vasculature Linear furrows/mucosal thickening White plaques Concentric rings/stricture Friability/"tissue-paper" mucosa Histology scoring tools Epithelial histology score Peak eosinophil count Each category could score 0-3 for a total maximum score of 15. The higher the score the worse the disease.
Outcome measures
| Measure |
Oral Viscous Budesonide Plus Prevacid
n=15 Participants
Budesonide plus Prevacid: Budesonide is taken daily for three months. In addition, Prevacid is taken twice daily for three months.
|
Placebo Plus Prevacid
n=9 Participants
placebo plus Prevacid: Placebo is taken daily for three months. In addition, Prevacid is taken twice daily for three months.
|
|---|---|---|
|
Upper Gastrointestinal Endoscopy Score
Baseline
|
4.6 units on a scale
Interval 0.0 to 9.0
|
7.8 units on a scale
Interval 4.0 to 9.0
|
|
Upper Gastrointestinal Endoscopy Score
3 months
|
1.5 units on a scale
Interval 0.0 to 7.0
|
5.4 units on a scale
Interval 1.0 to 9.0
|
SECONDARY outcome
Timeframe: Baseline and 3 MonthsTotal score was based on the following symptoms: Heartburn/regurgitation Abdominal pain Nausea/vomiting Anorexia/early satiety Dysphagia Symptom induced nocturnal wakening Gastrointestinal bleeding Each symptom could score 0-2 for a maximum score for 14 points. The lower the score the milder the symptoms and the higher the score the more severe symptoms.
Outcome measures
| Measure |
Oral Viscous Budesonide Plus Prevacid
n=15 Participants
Budesonide plus Prevacid: Budesonide is taken daily for three months. In addition, Prevacid is taken twice daily for three months.
|
Placebo Plus Prevacid
n=9 Participants
placebo plus Prevacid: Placebo is taken daily for three months. In addition, Prevacid is taken twice daily for three months.
|
|---|---|---|
|
Symptom Score
Baseline
|
3.5 units on a scale
Interval 0.0 to 10.0
|
2.7 units on a scale
Interval 1.0 to 6.0
|
|
Symptom Score
3 months
|
1.2 units on a scale
Interval 0.0 to 7.0
|
1.8 units on a scale
Interval 0.0 to 7.0
|
Adverse Events
Oral Viscous Budesonide Plus Prevacid
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo Plus Prevacid
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Oral Viscous Budesonide Plus Prevacid
n=21 participants at risk
Budesonide plus Prevacid: Budesonide is taken daily for three months. In addition, Prevacid is taken twice daily for three months.
|
Placebo Plus Prevacid
n=11 participants at risk
placebo plus Prevacid: Placebo is taken daily for three months. In addition, Prevacid is taken twice daily for three months.
|
|---|---|---|
|
Gastrointestinal disorders
Emesis
|
4.8%
1/21 • Number of events 1
|
0.00%
0/11
|
|
Gastrointestinal disorders
Oral Candida
|
4.8%
1/21 • Number of events 1
|
0.00%
0/11
|
|
Nervous system disorders
Trasient headache
|
4.8%
1/21 • Number of events 1
|
9.1%
1/11 • Number of events 1
|
|
General disorders
Worsening Eczema
|
0.00%
0/21
|
9.1%
1/11 • Number of events 1
|
|
Infections and infestations
Chest Infection
|
0.00%
0/21
|
9.1%
1/11 • Number of events 1
|
|
Gastrointestinal disorders
Mild Abdominal Pain
|
0.00%
0/21
|
9.1%
1/11 • Number of events 1
|
|
Gastrointestinal disorders
transient diarrehea
|
0.00%
0/21
|
9.1%
1/11 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place