Status:
COMPLETED
(CB-01-02/04) Extension Study of Budesonide Multi-Matrix System (MMX) 6 mg in Maintenance Of Remission In Patients With Ulcerative Colitis.
Lead Sponsor:
Bausch Health Americas, Inc.
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
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...
Eligibility Criteria
Inclusion
- Patients fulfilling the following criteria are eligible for participation in the study:
- Male and female patients, 18-75 years old, who are able to understand and voluntarily provide written informed consent.
- Patients in UCDAI remission defined as a UCDAI score ≤ 1 point with a score of 0 for rectal bleeding and stool frequency, and a ≥ 1 point reduction from baseline in the endoscopy score without any sign of mucosal friability (score 0 for mucosal appearance).
- Patients who have completed all End of Study assessments for the CB-01-02/01, CB-01-02/02 and CB-01-02/06 studies.
- Females of child-bearing potential must have had a serum pregnancy test performed at the End of Study visit of the parent studies and must use an acceptable contraceptive method throughout the study treatment period.
Exclusion
- Patients who meet any of the following criteria at screening visit are to be excluded from study participation:
- Subjects who have withdrawn from studies CB-01-02/01, CB 01 02/02 or CB-01-02/06.
- Subjects who did not achieve induction of remission according to the primary endpoint definition in studies CB-01-02/01, CB 01 02/02 or CB-01-02/06 (i.e. clinical remission defined as a UCDAI score ≤ 1 point with a score of 0 for rectal bleeding and stool frequency, and ≥ 1 point reduction from baseline in the endoscopy score without any sign of mucosal friability \[score 0 for mucosal appearance\]).
- Subjects with bone density lower than normal by age and sex (T-score lower than -1) as assessed via dual energy X-ray absorptiometry (DXA) scans.
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
123 Patients enrolled
Trial Details
Trial ID
NCT00801723
Start Date
December 1 2008
End Date
June 1 2011
Last Update
August 31 2020
Active Locations (58)
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1
Santarus Clinical Investigational Site 5051
Huntsville, Alabama, United States, 35801
2
Santarus Clinical Investigational Site 5088
Tucson, Arizona, United States, 85712
3
Santarus Clinical Investigational Site 5044
Anaheim, California, United States, 92801
4
Santarus Clinical Investigational Site 5087
Lakewood, California, United States, 90712