NCT01532648

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)

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral Budesonide MMX® 9 mg Extended-release Tablets as Add-on Therapy in Patients With Active, Mild or Moderate Ulcerative Colitis Not Adequately Controlled on a Background Oral 5-ASA Regimen

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 510 (actual)
• Sponsor: Bausch Health Americas, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Eligible participants will be randomized to 1 of the following 2 treatment arms: 1. Budesonide MMX 9 mg (1 tablet) 2. Placebo (tablet indistinguishable from budesonide MMX 9 mg tablet) The assigned study drug will be taken as a single oral tablet each morning after breakfast. In addition to the study drug, all participants will continue their existing background oral 5-ASA regimen during the treatment period.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	Budesonide MMX®	Oral tablet taken daily in the morning after breakfast.
DRUG	Placebo	Matching budesonide MMX placebo oral tablet taken daily in the morning after breakfast.
DRUG	5-ASA	Acceptable oral 5-ASA medications to be received during the study include: * Asacol®, Asacol® HD, Lialda®, Pentasa® (generic: mesalamine), minimum daily dose ≥2.4 grams (g) * Azulfidine® (generic: sulfasalazine), minimum daily dose ≥4.0 g * Dipentum® (generic: olsalazine), minimum daily dose ≥2.0 g * Colazal®, Colazide® (generic: balsalazide), minimum daily dose ≥6.75 g

Timeline

• Start date: 2012-01-27
• Primary completion: 2013-10-02
• Completion: 2013-10-02
• First posted: 2012-02-14
• Last updated: 2019-09-06
• Results posted: 2019-09-06

Locations

114 sites across 11 countries: United States, Bulgaria, Canada, Czechia, Estonia, Hungary, Latvia, Lithuania, Poland, Russia, Ukraine