(CB-01-02/01) Randomized Placebo Controlled Trial of Budesonide-multi-matrix System (MMX™) 6 mg and 9 mg in Patients With Ulcerative Colitis

Phase 3 Completed 510 enrolled Bausch Health Americas, Inc.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to compare Budesonide MMX™ 6 mg and Budesonide MMX™ 9 mg tablets to placebo and to Asacol 6x 400 mg tablets over an 8-week treatment period to determine if Budesonide MMX™ is effective in the treatment of ulcerative colitis.

Timeline

Start: 2008-06
Primary completion: 2010-05
Completion: 2010-06

Outcome

Met primary endpoint

registry 2: Budesonide-MMX® 9 mg vs 3: Placebo; p = 0.0143; Difference in proportions 10.4 (95% CI 2.2 to 18.7) NCT00679432 ↗

Publications

Results Sandborn WJ, Travis S, Moro L, Jones R, Gautille T, Bagin R, Huang M, Yeung P, Ballard ED 2nd. Once-daily budesonide MMX(R) extended-release tablets induce remission in patients with mild to moderate ulcerative colitis: results from the CORE I study. Gastroenterology. 2012 Nov;143(5):1218-1226.e2. doi: 10.1053/j.gastro.2012.08.003. Epub 2012 Aug 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Budesonide	Small molecule	6 mg	Oral
Subject	Budesonide	Small molecule	9 mg	Oral
Comparator	Mesalamine	Small molecule	2400 mg	—