Safety of an investigational formulation of budesonide (budesonide oral suspension) for eosinophilic oesophagitis: an integrated safety analysis of six phase 1-3 clinical trials.

Ikuo HiranoEvan S DellonSandeep K GuptaDavid A KatzkaMargaret H CollinsAbigail M WojtowiczBrian TerreriWenwen ZhangMena BoulesSiddharth BhatiaNirav K Desai

Published in: Alimentary pharmacology & therapeutics (2023)

SHP621-101 (no clinical trials registration number), MPI 101-01 (NCT00762073), MPI 101-06 (NCT01642212), SHP621-301 (NCT02605837), SHP621-302 (NCT02736409) and SHP621-303 (NCT03245840).

Keyphrases

clinical trial
phase ii
drug delivery
randomized controlled trial
double blind
study protocol
chronic rhinosinusitis