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

Colitis, Ulcerative Clinical Trial

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

Clinical Trial 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]).

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01100112
Study type Interventional
Source Bausch Health Americas, Inc.
Contact
Status Completed
Phase Phase 3
Start date February 2010
Completion date August 2010
View Details
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