Placebo rates in randomized controlled trials of proctitis therapy: A systematic review and meta-analysis.

Theshani A De SilvaLotus AlphonsusChristopher Ma Malcolm Hogan Rocio SedanoNeeraj NarulaSilvio DaneseLaurent Peyrin-BirouletJohn K MacDonaldSiddharth Singh Vipul Jairath

Published in: Journal of Crohn's & colitis (2022)

Placebo response and remission rates in proctitis trials are influenced by trial phase and the endpoint being assessed. These contemporary rates will inform trial design for novel therapeutics for treatment of proctitis, which is a large unmet need.

Keyphrases

phase iii
study protocol
randomized controlled trial
clinical trial
open label
small molecule
placebo controlled