Conditions: Colitis, Ulcerative
Keywords: ulcerative colitis Budesonide
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 61
Healthy volunteers: no

Brief 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.

Arms:
arm 1: Budesonide-MMX 9 mg tablet

Interventions: intervention 1: Budesonide
Intervention descriptions: intervention 1: One Budesonide-MMX 9 mg tablet will be taken in the morning after breakfast for 8 weeks.

Protocol document: