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

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ClinicalTrials.gov Identifier: NCT00679432
Recruitment Status : Completed
First Posted : May 16, 2008
Results First Posted : August 1, 2014
Last Update Posted : August 1, 2014
Sponsor:
Information provided by (Responsible Party):
Bausch Health Americas, Inc.

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
Hide Arm/Group Description

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
Hide Arm/Group Description

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
Hide Baseline Analysis Population Description
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
1.Primary Outcome
Title Clinical and Endoscopic Remission.
Hide Description Clinical and endoscopic remission defined as a Ulcerative Colitis Disease Activity Index (UCDAI) score ≤ 1, with subscores of 0 for rectal bleeding, stool frequency, and mucosal appearance and with a ≥ 1 point reduction in the endoscopic index score.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title 1: Budesonide-MMX® 6 mg 2: Budesonide-MMX® 9 mg 3: Placebo 4: Asacol® 400 mg
Hide Arm/Group Description:

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
Overall Number of Participants Analyzed 121 123 121 124
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
13.2
(7.2 to 19.3)
17.9
(11.1 to 24.7)
7.4
(2.8 to 12.1)
12.1
(6.4 to 17.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1: Budesonide-MMX® 6 mg, 3: Placebo
Comments All p-values were based on the Chi-square test; comparisons of budesonide MMX and placebo were conducted at the α = 0.025 level of significance and the comparison of Asacol and placebo were conducted at the α = 0.05 level of significance. The study was not powered to show statistical significance for Asacol versus budesonide MMX.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1393
Comments P-Value was adjusted for multiple comparisons; two budesonide dosage strengths were compared with placebo.
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in proportions
Estimated Value 5.8
Confidence Interval (2-Sided) 95%
-1.8 to 13.4
Estimation Comments The difference in proportions was determined by subtracting the proportion of patients who reached the endpoint in the placebo group from that proportion in the active group (active minus placebo).
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 2: Budesonide-MMX® 9 mg, 3: Placebo
Comments See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0143
Comments See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in proportions
Estimated Value 10.4
Confidence Interval (2-Sided) 95%
2.2 to 18.7
Estimation Comments See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 3: Placebo, 4: Asacol® 400 mg
Comments See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2200
Comments See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in proportions
Estimated Value 4.7
Confidence Interval (2-Sided) 95%
-2.7 to 12.1
Estimation Comments See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).
2.Secondary Outcome
Title Clinical Improvement.
Hide Description Clinical improvement, defined as a ≥ 3-point improvement in UCDAI from baseline to the end of Week 8.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title 1: Budesonide-MMX® 6 mg 2: Budesonide-MMX® 9 mg 3: Placebo 4: Asacol® 400 mg
Hide Arm/Group Description:

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
Overall Number of Participants Analyzed 121 123 121 124
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
30.6
(22.4 to 38.8)
33.3
(25.0 to 41.7)
24.8
(17.1 to 32.5)
33.9
(25.5 to 42.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1: Budesonide-MMX® 6 mg, 3: Placebo
Comments Clinical improvement and endoscopic improvement were analyzed hierarchically. If at least one primary endpoint comparison was statistically significant, clinical improvement was to be compared between each budesonide MMX group and placebo at the α = 0.025 level of significance. If at least one comparison of clinical improvement was statistically significant, endoscopic improvement was to be compared between each budesonide MMX dose group and placebo at the α = 0.025 level of significance.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3146
Comments P-Value was adjusted for multiple comparisons; two budesonide dosage strengths were compared with placebo.
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in proportions
Estimated Value 5.8
Confidence Interval (2-Sided) 95%
-5.5 to 17.0
Estimation Comments The difference in proportions was determined by subtracting the proportion of patients who reached the endpoint in the placebo group from that proportion in the active group (active minus placebo).
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 2: Budesonide-MMX® 9 mg, 3: Placebo
Comments See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1420
Comments See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in proportions
Estimated Value 8.5
Confidence Interval (2-Sided) 95%
-2.8 to 19.9
Estimation Comments See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 3: Placebo, 4: Asacol® 400 mg
Comments See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1189
Comments See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in proportions
Estimated Value 9.1
Confidence Interval (2-Sided) 95%
-2.3 to 20.4
Estimation Comments See comments from the budesonide 6 mg versus placebo comparison (statistical analysis 1).
3.Secondary Outcome
Title Endoscopic Improvement
Hide Description

Greater or equal to a 1 point improvement in the mucosal appearance subscore of the UCDAI, from baseline to week 8.

As per the hierarchical testing procedure for secondary endpoints, because clinical improvement was not statistically significant in the ITT population, formal statistical comparisons for endoscopic improvement between the 2 budesonide MMX groups and placebo were not conducted.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title 1: Budesonide-MMX® 6 mg 2: Budesonide-MMX® 9 mg 3: Placebo 4: Asacol® 400 mg
Hide Arm/Group Description:

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
Overall Number of Participants Analyzed 121 123 121 124
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
35.5
(27 to 44.1)
41.5
(32.8 to 50.2)
33.1
(24.7 to 41.4)
33.1
(24.8 to 41.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 3: Placebo, 4: Asacol® 400 mg
Comments As per the hierarchical testing procedure for secondary endpoints, because clinical improvement was not statistically significant in the ITT population, formal statistical comparisons for endoscopic improvement between the 2 budesonide MMX groups and placebo were not conducted. The statistical comparison between the Asacol and placebo groups is shown here.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9991
Comments P-Value was adjusted for multiple comparisons; two budesonide dosage strengths were compared with placebo.
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in proportions
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-11.8 to 11.8
Estimation Comments The difference in proportions was determined by subtracting the proportion of patients who reached the endpoint in the placebo group from that proportion in the active group (active minus placebo).
Time Frame 56 day ± 2 day (study duration) + 30 day safety followup period.
Adverse Event Reporting Description Adverse event data were analyzed using the safety population, defined as all patients who received study drug. 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
Hide Arm/Group Description

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
All-Cause Mortality
1: Budesonide-MMX® 6 mg 2: Budesonide-MMX® 9 mg 3: Placebo 4: Asacol® 400 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
1: Budesonide-MMX® 6 mg 2: Budesonide-MMX® 9 mg 3: Placebo 4: Asacol® 400 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/126 (1.59%)      3/127 (2.36%)      3/129 (2.33%)      4/127 (3.15%)    
Gastrointestinal disorders         
Colitis ulcerative † 1  1/126 (0.79%)  1 3/127 (2.36%)  3 1/129 (0.78%)  1 1/127 (0.79%)  1
Diarrhoea † 1  0/126 (0.00%)  0 1/127 (0.79%)  1 0/129 (0.00%)  0 0/127 (0.00%)  0
Large intestine perforation † 1  0/126 (0.00%)  0 1/127 (0.79%)  1 0/129 (0.00%)  0 0/127 (0.00%)  0
Pancreatitis † 1  0/126 (0.00%)  0 0/127 (0.00%)  0 0/129 (0.00%)  0 1/127 (0.79%)  1
Infections and infestations         
Pelvic abscess † 1  0/126 (0.00%)  0 0/127 (0.00%)  0 1/129 (0.78%)  1 0/127 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Renal cell carcinoma † 1  0/126 (0.00%)  0 0/127 (0.00%)  0 0/129 (0.00%)  0 1/127 (0.79%)  1
Nervous system disorders         
Cerebrovascular accident † 1  1/126 (0.79%)  1 0/127 (0.00%)  0 0/129 (0.00%)  0 0/127 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Asthma † 1  0/126 (0.00%)  0 1/127 (0.79%)  1 0/129 (0.00%)  0 0/127 (0.00%)  0
Skin and subcutaneous tissue disorders         
Pyoderma gangrenosum † 1  0/126 (0.00%)  0 0/127 (0.00%)  0 0/129 (0.00%)  0 1/127 (0.79%)  1
Vascular disorders         
Deep vein thrombosis † 1  0/126 (0.00%)  0 0/127 (0.00%)  0 1/129 (0.78%)  1 0/127 (0.00%)  0
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA V11.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
1: Budesonide-MMX® 6 mg 2: Budesonide-MMX® 9 mg 3: Placebo 4: Asacol® 400 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   35/126 (27.78%)      36/127 (28.35%)      34/129 (26.36%)      31/127 (24.41%)    
Blood and lymphatic system disorders         
Anaemia † 1  1/126 (0.79%)  1 0/127 (0.00%)  0 4/129 (3.10%)  4 2/127 (1.57%)  2
Gastrointestinal disorders         
Abdominal distension † 1  2/126 (1.59%)  3 4/127 (3.15%)  6 2/129 (1.55%)  2 4/127 (3.15%)  4
Abdominal pain † 1  2/126 (1.59%)  3 6/127 (4.72%)  7 8/129 (6.20%)  9 10/127 (7.87%)  10
Abdominal pain upper † 1  5/126 (3.97%)  8 5/127 (3.94%)  7 2/129 (1.55%)  3 2/127 (1.57%)  3
Abdominal tenderness † 1  3/126 (2.38%)  5 1/127 (0.79%)  1 2/129 (1.55%)  2 3/127 (2.36%)  3
Colitis ulcerative † 1  15/126 (11.90%)  15 12/127 (9.45%)  12 20/129 (15.50%)  20 12/127 (9.45%)  12
Diarrhoea † 1  5/126 (3.97%)  5 1/127 (0.79%)  1 7/129 (5.43%)  7 8/127 (6.30%)  9
Dyspepsia † 1  1/126 (0.79%)  1 1/127 (0.79%)  2 4/129 (3.10%)  4 5/127 (3.94%)  6
Flatulence † 1  1/126 (0.79%)  1 1/127 (0.79%)  1 2/129 (1.55%)  3 7/127 (5.51%)  7
Frequent bowel movements † 1  2/126 (1.59%)  3 1/127 (0.79%)  1 3/129 (2.33%)  4 4/127 (3.15%)  5
Nausea † 1  5/126 (3.97%)  6 5/127 (3.94%)  5 8/129 (6.20%)  10 10/127 (7.87%)  10
Vomiting † 1  5/126 (3.97%)  5 0/127 (0.00%)  0 4/129 (3.10%)  4 3/127 (2.36%)  5
General disorders         
Asthenia † 1  4/126 (3.17%)  5 0/127 (0.00%)  0 1/129 (0.78%)  1 1/127 (0.79%)  1
Fatigue † 1  3/126 (2.38%)  3 5/127 (3.94%)  5 3/129 (2.33%)  3 0/127 (0.00%)  0
Pyrexia † 1  5/126 (3.97%)  6 3/127 (2.36%)  4 9/129 (6.98%)  9 3/127 (2.36%)  3
Infections and infestations         
Influenza † 1  0/126 (0.00%)  0 0/127 (0.00%)  0 3/129 (2.33%)  3 1/127 (0.79%)  1
Nasopharyngitis † 1  5/126 (3.97%)  5 3/127 (2.36%)  3 4/129 (3.10%)  4 3/127 (2.36%)  4
Upper respiratory tract infection † 1  5/126 (3.97%)  5 2/127 (1.57%)  2 3/129 (2.33%)  3 1/127 (0.79%)  1
Urinary tract infection † 1  1/126 (0.79%)  1 5/127 (3.94%)  5 1/129 (0.78%)  1 3/127 (2.36%)  3
Investigations         
Alanine aminotransferase increased † 1  0/126 (0.00%)  0 0/127 (0.00%)  0 0/129 (0.00%)  0 3/127 (2.36%)  3
Blood cortisol decreased † 1  3/126 (2.38%)  3 4/127 (3.15%)  4 0/129 (0.00%)  0 0/127 (0.00%)  0
Blood urine present † 1  0/126 (0.00%)  0 0/127 (0.00%)  0 0/129 (0.00%)  0 3/127 (2.36%)  4
Musculoskeletal and connective tissue disorders         
Arthralgia † 1  1/126 (0.79%)  1 3/127 (2.36%)  3 2/129 (1.55%)  2 4/127 (3.15%)  5
Back pain † 1  4/126 (3.17%)  4 5/127 (3.94%)  5 7/129 (5.43%)  9 2/127 (1.57%)  2
Musculoskeletal pain † 1  0/126 (0.00%)  0 0/127 (0.00%)  0 0/129 (0.00%)  0 3/127 (2.36%)  3
Pain in extremity † 1  1/126 (0.79%)  1 2/127 (1.57%)  2 4/129 (3.10%)  8 2/127 (1.57%)  3
Nervous system disorders         
Dizziness † 1  6/126 (4.76%)  7 0/127 (0.00%)  0 1/129 (0.78%)  1 4/127 (3.15%)  5
Headache † 1  17/126 (13.49%)  29 8/127 (6.30%)  14 19/129 (14.73%)  31 12/127 (9.45%)  15
Somnolence † 1  1/126 (0.79%)  1 1/127 (0.79%)  1 0/129 (0.00%)  0 3/127 (2.36%)  3
Psychiatric disorders         
Insomnia † 1  6/126 (4.76%)  8 5/127 (3.94%)  5 9/129 (6.98%)  10 3/127 (2.36%)  4
Mood altered † 1  4/126 (3.17%)  5 2/127 (1.57%)  2 2/129 (1.55%)  2 3/127 (2.36%)  3
Renal and urinary disorders         
Pollakiuria † 1  4/126 (3.17%)  4 0/127 (0.00%)  0 0/129 (0.00%)  0 1/127 (0.79%)  1
Skin and subcutaneous tissue disorders         
Acne † 1  1/126 (0.79%)  1 4/127 (3.15%)  5 2/129 (1.55%)  2 4/127 (3.15%)  4
Rash † 1  0/126 (0.00%)  0 2/127 (1.57%)  2 5/129 (3.88%)  6 3/127 (2.36%)  4
Vascular disorders         
Flushing † 1  0/126 (0.00%)  0 0/127 (0.00%)  0 2/129 (1.55%)  2 3/127 (2.36%)  3
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA V11.0
[Not Specified]
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
Layout table for Results Point of Contact information
Name/Title: Michael Huang, MD, Senior Medical Director, Clinical Research
Organization: Santarus, Inc.
Phone: 8583145700
EMail: mhuang@santarus.com
Publications of Results:
Sandborn WJ, Travis S, Moro L, Jones R, Gautille T, Bagin R, Huang M, Yeung P, Ballard ED 2nd. Once-daily budesonide MMX® extended-release tablets induce remission in patients with mild to moderate ulcerative colitis: results from the CORE I study. Gastroenterology. 2012 Nov;143(5):1218-1226.e2. doi: 10.1053/j.gastro.2012.08.003. Epub 2012 Aug 11.
Layout table for additonal information
Responsible Party: Bausch Health Americas, Inc.
ClinicalTrials.gov Identifier: NCT00679432     History of Changes
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: August 1, 2014