(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

Participant Flow

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
Arm/Group Description	One budesonide-MMX® 6 mg plus two p...	One budesonide-MMX® 9 mg plus two p...	Two placebo Asacol® overencapsulate...	Two Asacol® 400 mg overencapsulated...
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

Baseline Characteristics

Arm/Group Title		1: Budesonide-MMX® 6 mg	2: Budesonide-MMX® 9 mg	3: Placebo	4: Asacol® 400 mg	Total
Arm/Group Description		One budesonide-MMX® 6 mg plus two p...	One budesonide-MMX® 9 mg plus two p...	Two placebo Asacol® overencapsulate...	Two Asacol® 400 mg overencapsulated...	Total of all reporting groups
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
Baseline Analysis Population Description		...
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

Outcome Measures

1.Primary Outcome


Title	Clinical and Endoscopic Remission.
Description	Clinical and endoscopic remission defined as a Ulcerative Colitis Dise...
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

Outcome Measure Data

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
Arm/Group Description:	One budesonide-MMX® 6 mg plus two p...	One budesonide-MMX® 9 mg plus two p...	Two placebo Asacol® overencapsulate...	Two Asacol® 400 mg overencapsulated...
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)

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).

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).

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.
Description	Clinical improvement, defined as a ≥ 3-point improvement in UCDA...
Description	Clinical improvement, defined as a ≥ 3-point improvement in UCDAI from baseline to the end of Week 8.
Time Frame	8 weeks

Outcome Measure Data

Analysis Population Description


Arm/Group Title	1: Budesonide-MMX® 6 mg	2: Budesonide-MMX® 9 mg	3: Placebo	4: Asacol® 400 mg
Arm/Group Description:	One budesonide-MMX® 6 mg plus two p...	One budesonide-MMX® 9 mg plus two p...	Two placebo Asacol® overencapsulate...	Two Asacol® 400 mg overencapsulated...
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)

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).

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).

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
Description	Greater or equal to a 1 ...
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

Outcome Measure Data

Analysis Population Description


Arm/Group Title	1: Budesonide-MMX® 6 mg	2: Budesonide-MMX® 9 mg	3: Placebo	4: Asacol® 400 mg
Arm/Group Description:	One budesonide-MMX® 6 mg plus two p...	One budesonide-MMX® 9 mg plus two p...	Two placebo Asacol® overencapsulate...	Two Asacol® 400 mg overencapsulated...
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)

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).

Adverse Events

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
Arm/Group Description	One budesonide-MMX® 6 mg plus two p...		One budesonide-MMX® 9 mg plus two p...		Two placebo Asacol® overencapsulate...		Two Asacol® 400 mg overencapsulated...
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	--/--		--/--		--/--		--/--
Serious Adverse Events 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
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

Limitations and Caveats

[Not Specified]

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

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.

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

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