Budesonide Versus Mesalazine Versus Placebo in Lymphocytic Colitis

Summary

The purpose of this study is to determine whether budesonide or mesalazine is more active in the treatment of lymphocytic colitis.

Timeline

Start

2010-05

Primary completion

2017-06

Completion

2017-06

Outcome

Mixed primary results

paper budesonide group than in the placebo group (intention-to-treat analysis, 79% vs 42%; P = .01). PMID 30195447 ↗

paper between the mesalazine (63%) and placebo groups was not significant (P = .09). PMID 30195447 ↗

Publications

• Miehlke S, Aust D, Mihaly E, Armerding P, Bohm G, Bonderup O, Fernandez-Banares F, Kupcinskas J, Munck LK, Rehbehn KU, Nacak T, Greinwald R, Munch A; BUG-1/LMC Study Group. Efficacy and Safety of Budesonide, vs Mesalazine or Placebo, as Induction Therapy for Lymphocytic Colitis. Gastroenterology. 2018 Dec;155(6):1795-1804.e3. doi: 10.1053/j.gastro.2018.08.042. Epub 2018 Sep 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Budesonide	Small molecule	9 mg	Oral
Subject	Mesalamine	Small molecule	3 g	Oral

Indications