Randomized Placebo-Controlled Trial of Budesonide Multi-Matrix System (MMX®) 9 Milligrams (mg) in Participants With Ulcerative Colitis Currently on a 5-Aminosalicylic Acid (5-ASA)

Phase 3 Completed 510 enrolled Bausch Health Americas, Inc.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study is to compare the efficacy and safety of budesonide MMX 9 mg versus placebo as add-on therapy to an existing oral 5-ASA regimen for the induction of remission in participants with active mild or moderate ulcerative colitis (UC).

Timeline

Start: 2012-01-27
Primary completion: 2013-10-02
Completion: 2013-10-02

Publications

Rubin DT, Cohen RD, Sandborn WJ, Lichtenstein GR, Axler J, Riddell RH, Zhu C, Barrett AC, Bortey E, Forbes WP. Budesonide Multimatrix Is Efficacious for Mesalamine-refractory, Mild to Moderate Ulcerative Colitis: A Randomised, Placebo-controlled Trial. J Crohns Colitis. 2017 Jul 1;11(7):785-791. doi: 10.1093/ecco-jcc/jjx032.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Budesonide	Small molecule	9 mg	Oral
Background	Balsalazide	Small molecule	6.75 g	Oral
Background	Mesalamine	Small molecule	2.4 g	Oral
Background	Sulfasalazine	Small molecule	4 g	Oral
Background	olsalazine	Small molecule	2 g	Oral

Randomized Placebo-Controlled Trial of Budesonide Multi-Matrix System (MMX®) 9 Milligrams (mg) in Participants With Ulcerative Colitis Currently on a 5-Aminosalicylic Acid (5-ASA)

Summary

Timeline

Publications

Drugs

Indications