Prospective Evaluation of Budesonide for Prevention of Esophageal Strictures After Endotherapy

PHASE2CompletedINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

February 28, 2014

Primary Completion Date

January 11, 2019

Study Completion Date

January 11, 2019

Conditions
Esophageal Stricture
Interventions
DRUG

Budesonide

"Participants will be instructed to swallow budesonide 3mg twice daily for eight consecutive weeks following endotherapy with EMR or ESD. Budesonide will be provided in a capsule containing 3mg budesonide only by Mayo Clinic Pharmacy with full 8 weeks supply.~The patient will require opening the capsule and mixing the budesonide powder in 10ml (2 teaspoons) honey, or pancake syrup.~Patients will be instructed not to ingest any solid or liquids for 30 minutes before and after taking the budesonide. For purposes of this study, budesonide is used off-label but according to the same dose and efficacy as has been demonstrated in other esophageal inflammatory conditions. Patients will receive a handout with exact instructions how and when to take Budesonide."

Trial Locations (1)

32224

Mayo Clinic in Florida, Jacksonville

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Mayo Clinic

OTHER

NCT02069847 - Prospective Evaluation of Budesonide for Prevention of Esophageal Strictures After Endotherapy | Biotech Hunter | Biotech Hunter