At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 61 enrolled
Drug / intervention
Budesonidedrug
Likely dose
Budesonide 9 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Multicenter, Open-Label Efficacy and Safety Study of Oral Budesonide-MMX 9mg Extended Release Tablets in Patients With Mild to Moderate, Active Ulcerative Colitis
In Brief
A Phase 3 clinical trial evaluating Budesonide for Colitis, Ulcerative. Completed, enrolled 61 participants across 15 sites.
Detailed 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 \[NCT00679432\]).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsColitis, Ulcerative
CountriesIndia
CollaboratorsCosmo Technologies Ltd
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartFeb 2010
First PostedApr 2010
Primary CompletionJul 2010
Study CompletionAug 2010
TodayJul 2026
First PostedApr 8, 2010
Enrollment StartFeb 1, 2010
Primary CompletionJul 1, 2010
Study CompletionAug 1, 2010
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 16.2 years ago
Interventions
Budesonidedrug
One Budesonide-MMX 9 mg tablet will be taken in the morning after breakfast for 8 weeks.