(CB-01-02/04) Extension Study of Budesonide Multi-Matrix System (MMX) 6 mg in Maintenance Of Remission In Patients With Ulcerative Colitis.
Randomized, double-blind, comparative study versus placebo performed in patients from studies CB-01-02/01 (NCT00679432), CB-01-02/02 (NCT00679380), or CB-01-02/06 (NCT01100112) who achieved ulcerative colitis disease activity index (UCDAI) remission after 8 weeks of treatment.
Patients in remission at the End of Study visit will be given the opportunity to enter the 12-month Maintenance Phase study outlined in this protocol (CB-01-02/04). The End of Study visit in studies 01, 02, and 06 will be set as the Visit 1 (Day 0) of this study. There will be no interruption of study treatment between the parent studies and this study.
It is planned that approximately 150 patients will be enrolled in the study. Patients will be randomly assigned to two groups to receive either budesonide MMX 6 mg or placebo irrespective of the treatment assigned in studies 01, 02, or 06. Treatments will be administered once a day after breakfast for a maximum of 12 months or up to the occurrence of the first clinical relapse, where clinical relapse is defined as combined recurrence of rectal bleeding and stool frequency ≥ 1-2 stools/day above normal for the patient (score ≥ 1 in both UCDAI items).
During the study, patients will be assessed for safety and efficacy at Visit 1 and after 1, 3, 6, 9, and 12 months of treatment.
Patients will be contacted by telephone on a monthly basis for safety assessment. In case of occurrence of symptoms suggestive of clinical relapse, patients will attend an unscheduled visit at any time during the study.
|Ulcerative Colitis||Drug: Budesonide MMX 6 mg Tablet Drug: Placebo Tablet||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Randomised, Double-Blind, Multi-Centre, 12 Month Extension Study to Evaluate the Safety And Efficacy of Daily Budesonide MMX 6 mg Versus Placebo in the Maintenance of Remission in Subjects With Ulcerative Colitis.|
- Clinical remission at 1, 3, 6, 9, and 12 months, where clinical remission is defined as the combined absence of recurrence of rectal bleeding and absence of increased stool frequency. [ Time Frame: 12 months ]
- Time to clinical relapse [ Time Frame: 12 months ]
- Endoscopic relapse [ Time Frame: 12 months ]
|Study Start Date:||December 2008|
|Study Completion Date:||June 2011|
|Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
Experimental: 1: Budesonide MMX® 6 mg
One Budesonide-MMX® 6 mg tablet self-administered by the patients with a glass of water, in the morning after breakfast.
Drug: Budesonide MMX 6 mg Tablet
Budesonide MMX 6 mg Tablet once daily.
Placebo Comparator: 2: Placebo
One placebo tablet self-administered by the patients with a glass of water, in the morning after breakfast.
Drug: Placebo Tablet
Placebo Tablet once daily.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00801723
Show 58 Study Locations
|Principal Investigator:||Bruce Eric Sands||Massachusetts General Hospital|
|Principal Investigator:||Simon Travis||Oxford University Hospitals NHS Trust|