(CB-01-02/01) Randomized Placebo Controlled Trial of Budesonide-multi-matrix System (MMX™) 6 mg and 9 mg in Patients With Ulcerative Colitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Salix Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00679432
First received: May 14, 2008
Last updated: July 3, 2014
Last verified: July 2014
Results First Received: April 25, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, 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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruited from August 2008 until May 2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
1: Budesonide-MMX® 6 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

2: Budesonide-MMX® 9 mg

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

3: Placebo

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

4: Asacol® 400 mg

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


Participant Flow:   Overall Study
    1: Budesonide-MMX® 6 mg     2: Budesonide-MMX® 9 mg     3: Placebo     4: Asacol® 400 mg  
STARTED     126     127     129     127  
COMPLETED     89     89     76     95  
NOT COMPLETED     37     38     53     32  
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  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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).

Reporting Groups
  Description
1: Budesonide-MMX® 6 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

2: Budesonide-MMX® 9 mg

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

3: Placebo

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

4: Asacol® 400 mg

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 Total of all reporting groups

Baseline Measures
    1: Budesonide-MMX® 6 mg     2: Budesonide-MMX® 9 mg     3: Placebo     4: Asacol® 400 mg     Total  
Number of Participants  
[units: participants]
  121     123     121     124     489  
Age  
[units: participants]
         
<=18 years     0     0     0     0     0  
Between 18 and 65 years     117     122     115     118     472  
>=65 years     4     1     6     6     17  
Age  
[units: years]
Mean ± Standard Deviation
  43.2  ± 13     41.7  ± 12.2     41.7  ± 13.6     44  ± 12.4     42.7  ± 12.8  
Gender  
[units: participants]
         
Female     62     46     53     55     216  
Male     59     77     68     69     273  
Region of Enrollment  
[units: participants]
         
United States     75     76     77     76     304  
Canada     5     7     5     6     23  
India     41     40     39     42     162  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Clinical and Endoscopic Remission.   [ Time Frame: 8 weeks ]

2.  Secondary:   Clinical Improvement.   [ Time Frame: 8 weeks ]

3.  Secondary:   Endoscopic Improvement   [ Time Frame: 8 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Michael Huang, MD, Senior Medical Director, Clinical Research
Organization: Santarus, Inc.
phone: 8583145700
e-mail: mhuang@santarus.com


Publications of Results:

Responsible Party: Salix Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00679432     History of Changes
Other Study ID Numbers: CB-01-02/01
Study First Received: May 14, 2008
Results First Received: April 25, 2014
Last Updated: July 3, 2014
Health Authority: United States: Food and Drug Administration