Trial Outcomes & Findings for Study of the Efficiency of Esophageal Dilation on Patient With Eosinophilic Esophagitis (NCT NCT00880906)

Results Overview

Dysphagia Scores: 0 = able to eat normal diet / no dysphagia. 1. = able to swallow some solid foods 2. = able to swallow only semi solid foods 3. = able to swallow liquids only 4. = unable to swallow anything / total dysphagia

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

50 participants

Primary outcome timeframe

60 days

Results posted on

2017-11-06

Participant Flow

Participant milestones

Participant milestones
Measure	Group A Drug Therapy Plus Dilation Group A receives steroids and PPI, (SOC) and esophageal dilation. Esophageal dilation: The esophagus is stretched during the upper endoscopy using Maloney dilators or balloon dilatation.	Group B Drug Therapy Only Receives steroids and PPI only- Does not have esophageal dilation.
Overall Study STARTED	29	21
Overall Study COMPLETED	17	14
Overall Study NOT COMPLETED	12	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Group A Drug Therapy Plus Dilation Group A receives steroids and PPI, (SOC) and esophageal dilation. Esophageal dilation: The esophagus is stretched during the upper endoscopy using Maloney dilators or balloon dilatation.	Group B Drug Therapy Only Receives steroids and PPI only- Does not have esophageal dilation.
Overall Study Lost to Follow-up	0	1
Overall Study Did not meet criteria following patholog	12	6

Baseline Characteristics

Study of the Efficiency of Esophageal Dilation on Patient With Eosinophilic Esophagitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group A Receives Routine Care and Esophageal Dilatation n=29 Participants Group A receives steroids and PPI, (SOC) and esophageal dilation. Esophageal dilation: The esophagus is stretched during the upper endoscopy using Maloney dilators or balloon dilatation.	Group B Receives SOC Only n=21 Participants Receives steroids and PPI only- Does not have esophageal dilation.	Total n=50 Participants Total of all reporting groups
Age, Continuous	35 Years n=5 Participants	32 Years n=7 Participants	33 Years n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	29 Participants n=5 Participants	20 Participants n=7 Participants	49 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	9 Participants n=7 Participants	22 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	12 Participants n=7 Participants	28 Participants n=5 Participants
Region of Enrollment United States	29 participants n=5 Participants	21 participants n=7 Participants	50 participants n=5 Participants

PRIMARY outcome

Timeframe: 60 days

Dysphagia Scores: 0 = able to eat normal diet / no dysphagia. 1. = able to swallow some solid foods 2. = able to swallow only semi solid foods 3. = able to swallow liquids only 4. = unable to swallow anything / total dysphagia

Outcome measures

Outcome measures
Measure	Group A Receives Routine Care and Esophageal Dilatation n=17 Participants Group A receives steroids and PPI, (SOC) and esophageal dilation. Esophageal dilation: The esophagus is stretched during the upper endoscopy using Maloney dilators or balloon dilatation.	Group B Receives SOC Only n=14 Participants Receives steroids and PPI only- Does not have esophageal dilation.
Percent Change From Baseline in Dysphagia Score in Patients With Eosinophilic Esophagitis (EE)	69 Percent Change	79 Percent Change

SECONDARY outcome

Timeframe: 60 days

Population: Saved samples were not analyzed due to there being no difference in the primary outcome measure.

Outcome measures

Outcome data not reported

Adverse Events

Group A Receives Routine Care and Esophageal Dilatation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group B Receives SOC Only

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Michael Vaezi, MD, PhD

Vanderbilt University

Phone: 615-322-3739

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place