Comparison of Esophageal Clearance Times of Oral Budesonide Preparations

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT02125851
• Date of registration: 21/02/2014
• Prospective Registration: No
• Primary sponsor: Walter Reed National Military Medical Center
• Public title: Comparison of Esophageal Clearance Times of Oral Budesonide Preparations
• Scientific title: Comparison of Esophageal Clearance Times of Oral Budesonide Preparations
• Date of first enrolment: January 2014
• Target sample size: 24
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT02125851
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Jody N Hefner, DO
• Affiliation: Walter Reed National Military Medical Center

Key inclusion & exclusion criteria

Inclusion Criteria:

1. DEERS eligible

2. Older than 18 y/o, without diagnosis of Eosinophilic Esophagitis or other esophageal
disease

Exclusion Criteria:

1. History of EoE, esophageal surgery or known achalasia/stricture or previously
diagnosed GERD or GER that requires more frequent than once a week treatment.

2. Peripheral eosinophil count above 0.5 X10^3 / mcL.

3. Pregnancy or breastfeeding

4. Previous adverse reaction to budesonide, honey, or oranges.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Eosinophilic Esophagitis

Intervention(s)

Other: Honey

Other: Xanthan Gum

Primary Outcome(s)

Esophageal Mucosal Contact Time [Time Frame: 1 hour]

Secondary Outcome(s)

Taste preference [Time Frame: 1 minute after slurry is ingested]

Secondary ID(s)

385682-2

Source(s) of Monetary Support

Please refer to primary and secondary sponsors