NCT01100112

(CB-01-02/06) Oral Budesonide-Multi-Matrix System (MMX) 9mg Extended Release Tablets

Multicenter, Open-Label Efficacy and Safety Study of Oral Budesonide-MMX 9mg Extended Release Tablets in Patients With Mild to Moderate, Active Ulcerative Colitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Bausch Health Americas, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Open-label, 8 week study, to assess the efficacy and safety of oral Budesonide-MMX 9 mg Extended-release Tablets in patients with mild to moderate, active ulcerative colitis who are not in remission based on the Ulcerative Colitis Disease Activity Index in study CB-01-02/01 (parent study \[NCT00679432\]).

Detailed description

Patients who complete the parent study and who do not achieve clinical remission will be eligible to receive 8 weeks of open-label treatment with Budesonide-MMX 9mg if they satisfy the entry criteria for this study.

Conditions

• Colitis, Ulcerative

Interventions

Type	Name	Description
DRUG	Budesonide	One Budesonide-MMX 9 mg tablet will be taken in the morning after breakfast for 8 weeks.

Timeline

• Start date: 2010-02-01
• Primary completion: 2010-07-01
• Completion: 2010-08-01
• First posted: 2010-04-08
• Last updated: 2019-11-29
• Results posted: 2014-06-05

Locations

15 sites across 1 country: India