SOIBD Collagenous Colitis Maintenance Study

Phase 3 Completed 92 enrolled Dr. Falk Pharma GmbH The Swedish Organization for Studies on Inflammatory Bowel Disease · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study aims to demonstrate the superiority of budesonide compared to placebo as maintenance therapy in keeping patients in remission over a one-year period

Timeline

Start: 2008-04
Primary completion: 2013-03
Completion: 2013-09

Outcome

Met primary endpoint

paper treatment difference 44.5% in favour of budesonide; 95% CI (26.9% to 62.7%), p<0.001. PMID 25425655 ↗

Publications

Results Munch A, Bohr J, Miehlke S, Benoni C, Olesen M, Ost A, Strandberg L, Hellstrom PM, Hertervig E, Armerding P, Stehlik J, Lindberg G, Bjork J, Lapidus A, Lofberg R, Bonderup O, Avnstrom S, Rossle M, Dilger K, Mueller R, Greinwald R, Tysk C, Strom M; BUC-63 investigators. Low-dose budesonide for maintenance of clinical remission in collagenous colitis: a randomised, placebo-controlled, 12-month trial. Gut. 2016 Jan;65(1):47-56. doi: 10.1136/gutjnl-2014-308363. Epub 2014 Nov 25.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Budesonide	Small molecule	4.5 mg	—

Indications

No indication recorded.