Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

(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):
Valeant Pharmaceuticals International, Inc.
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
  Hide Participant Flow

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
  Hide Baseline Characteristics

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 
Overall Participants Analyzed 
[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
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

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: Valeant Pharmaceuticals International, Inc.
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