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)
Last updated on July 2021Recruitment
- Recruitment Status
- Completed
- Estimated Enrollment
- 500
Summary
- Conditions
- Ulcerative Colitis
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 75 years
- Gender
- Both males and females
Description
Eligible participants will be randomized to 1 of the following 2 treatment arms: Budesonide MMX 9 mg (1 tablet) 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...
Eligible participants will be randomized to 1 of the following 2 treatment arms: Budesonide MMX 9 mg (1 tablet) 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.
Tracking Information
- NCT #
- NCT01532648
- Collaborators
- Not Provided
- Investigators
- Study Director: Lindsey Mathew Bausch Health Companies
Get Well Soon