(CB-01-02/01) Randomized Placebo Controlled Trial of Budesonide-multi-matrix System (MMX™) 6 mg and 9 mg in Patients With Ulcerative Colitis
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00679432 |
Recruitment Status :
Completed
First Posted : May 16, 2008
Results First Posted : August 1, 2014
Last Update Posted : December 10, 2019
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Study Type | Interventional |
---|---|
Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Condition |
Ulcerative Colitis |
Interventions |
Procedure: Blood sampling, endoscopy Drug: budesonide-MMX® 6 mg Drug: budesonide-MMX® 9 mg Drug: Placebo Drug: Asacol® 400 mg |
Enrollment | 510 |
Recruitment Details | Recruited from August 2008 until May 2010. |
Pre-assignment Details | Diary data for symptoms will be collected prior to randomization. Lab testing and a colonoscopy will be done prior to randomization. 510 patients were randomized. One patient was not treated and was not included in baseline characteristics, efficacy, and safety analyses. 509 patients received study drug and were included in safety analyses. |
Arm/Group Title | 1: Budesonide-MMX® 6 mg | 2: Budesonide-MMX® 9 mg | 3: Placebo | 4: Asacol® 400 mg |
---|---|---|---|---|
![]() |
One budesonide-MMX® 6 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks. budesonide-MMX® 6 mg : 6 mg/day, 6 mg tablets Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores |
One budesonide-MMX® 9 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks. Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores budesonide-MMX® 9 mg : 9 mg/day, 9 mg tablets |
Two placebo Asacol® overencapsulated tablets plus one placebo Budesonide MMX® tablet daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks. Placebo : Placebo Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores |
Two Asacol® 400 mg overencapsulated tablets plus one placebo budesonide MMX® tablet daily in the morning after breakfast and two Asacol® 400 mg overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks. Asacol® 400 mg : 2400 mg/day, 400 mg tablets Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores |
Period Title: Overall Study | ||||
Started | 126 | 127 | 129 | 127 |
Completed | 89 | 89 | 76 | 95 |
Not Completed | 37 | 38 | 53 | 32 |
Reason Not Completed | ||||
Adverse Event | 5 | 6 | 10 | 7 |
Protocol Violation | 1 | 1 | 2 | 1 |
Withdrawal by Subject | 8 | 11 | 10 | 9 |
Lost to Follow-up | 1 | 5 | 4 | 2 |
Physician Decision | 3 | 2 | 2 | 2 |
Sponsor decision | 1 | 0 | 0 | 0 |
Lack of Efficacy | 13 | 9 | 14 | 8 |
Infectious colitis, normal histology | 5 | 4 | 8 | 3 |
Randomization error, return to prior Rx | 0 | 0 | 3 | 0 |
Arm/Group Title | 1: Budesonide-MMX® 6 mg | 2: Budesonide-MMX® 9 mg | 3: Placebo | 4: Asacol® 400 mg | Total | |
---|---|---|---|---|---|---|
![]() |
One budesonide-MMX® 6 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks. budesonide-MMX® 6 mg : 6 mg/day, 6 mg tablets Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores |
One budesonide-MMX® 9 mg plus two placebo Asacol® overencapsulated tablets daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks. Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores budesonide-MMX® 9 mg : 9 mg/day, 9 mg tablets |
Two placebo Asacol® overencapsulated tablets plus one placebo Budesonide MMX® tablet daily in the morning after breakfast and two placebo Asacol® overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks. Placebo : Placebo Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores |
Two Asacol® 400 mg overencapsulated tablets plus one placebo budesonide MMX® tablet daily in the morning after breakfast and two Asacol® 400 mg overencapsulated tablets daily after the mid-day meal and the evening meal for eight weeks. Asacol® 400 mg : 2400 mg/day, 400 mg tablets Blood sampling, endoscopy : Blood sampling for hematology and biochemistry and endoscopy with biopsy for histological and endoscopic assessment scores |
Total of all reporting groups | |
Overall Number of Baseline Participants | 121 | 123 | 121 | 124 | 489 | |
![]() |
Intent-to-Treat (ITT) population= primary population for efficacy/baseline characteristics analyses. ITT population= randomized patients who received study drug, and did not include patients with major entry criteria/GCP violations or normal histology at baseline (N= 509 randomized - 3[infectious colitis] - 17[normal histology at baseline] = 489).
|
|||||
Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
||||||
Number Analyzed | 121 participants | 123 participants | 121 participants | 124 participants | 489 participants | |
<=18 years |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Between 18 and 65 years |
117 96.7%
|
122 99.2%
|
115 95.0%
|
118 95.2%
|
472 96.5%
|
|
>=65 years |
4 3.3%
|
1 0.8%
|
6 5.0%
|
6 4.8%
|
17 3.5%
|
|
Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
||||||
Number Analyzed | 121 participants | 123 participants | 121 participants | 124 participants | 489 participants | |
43.2 (13) | 41.7 (12.2) | 41.7 (13.6) | 44 (12.4) | 42.7 (12.8) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
||||||
Number Analyzed | 121 participants | 123 participants | 121 participants | 124 participants | 489 participants | |
Female |
62 51.2%
|
46 37.4%
|
53 43.8%
|
55 44.4%
|
216 44.2%
|
|
Male |
59 48.8%
|
77 62.6%
|
68 56.2%
|
69 55.6%
|
273 55.8%
|
|
Region of Enrollment
Measure Type: Number Unit of measure: Participants |
Number Analyzed | 121 participants | 123 participants | 121 participants | 124 participants | 489 participants |
United States | 75 | 76 | 77 | 76 | 304 | |
Canada | 5 | 7 | 5 | 6 | 23 | |
India | 41 | 40 | 39 | 42 | 162 |
Name/Title: | Michael Huang, MD, Senior Medical Director, Clinical Research |
Organization: | Santarus, Inc. |
Phone: | 8583145700 |
EMail: | mhuang@santarus.com |
Responsible Party: | Bausch Health Americas, Inc. |
ClinicalTrials.gov Identifier: | NCT00679432 |
Other Study ID Numbers: |
CB-01-02/01 |
First Submitted: | May 14, 2008 |
First Posted: | May 16, 2008 |
Results First Submitted: | April 25, 2014 |
Results First Posted: | August 1, 2014 |
Last Update Posted: | December 10, 2019 |