Oral and Gastrointestinal
A phase II, double-blind, randomised, placebo-controlled trial to evaluate the efficacy and tolerability of ZED1227 in celiac disease subjects experiencing symptoms despite gluten-free diet (CEC-013/CEL)
This is a double-blind, randomised, multicentre, placebo-controlled, comparative phase II efficacy trial. The trial will be conducted with two treatment groups in the form of a parallel group comparison and will serve to compare oral treatment with daily doses of 75 mg [25 mg three times a day (TID)] and potentially 30 mg (10 mg TID) of ZED1227 vs placebo for treatment of celiac disease.
The screening period will be up to 4 weeks, followed by a 3-week single-blind placebo run-in ...
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