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Safety and Efficacy of Two Different Doses of Asacol in the Treatment of Moderately Active 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: NCT00073021
Recruitment Status : Completed
First Posted : November 17, 2003
Results First Posted : July 28, 2011
Last Update Posted : June 29, 2015
Sponsor:
Information provided by (Responsible Party):
Warner Chilcott

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Ulcerative Colitis
Interventions Drug: Asacol 800 mg (mesalamine)
Drug: Asacol 400 mg (mesalamine)
Enrollment 386
Recruitment Details Recruitment began Feb. 28, 2001. Randomized 386 patients of which 117 had mild disease and 268 had moderate disease at baseline. Analysis only includes patients with moderate disease at baseline.
Pre-assignment Details  
Arm/Group Title Asacol 2.4 g/Day Asacol 4.8 g/Day
Hide Arm/Group Description Two 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg formulation) taken 3 times daily (morning, midday, evening). Two 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg formulation) taken 3 times daily (morning, midday, evening).
Period Title: Overall Study
Started 139 [1] 129 [1]
Completed 113 113
Not Completed 26 16
Reason Not Completed
Protocol Violation             2             1
Adverse Event             4             4
Withdrawal by Subject             6             5
Physician Decision             3             1
Lack of Efficacy             11             5
[1]
Subjects with Moderate Disease [PGA = 2] at Baseline
Arm/Group Title Asacol 2.4 g/Day Asacol 4.8 g/Day Total
Hide Arm/Group Description Two 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg formulation) taken 3 times daily (morning, midday, evening). Two 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg formulation) taken 3 times daily (morning, midday, evening). Total of all reporting groups
Overall Number of Baseline Participants 139 129 268
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 139 participants 129 participants 268 participants
18 - 64 years 126 118 244
>= 65 years 13 11 24
[1]
Measure Description: All Randomized Patients with Moderate Disease [PGA (Physician's Global Assessment) = 2] at Baseline
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 139 participants 129 participants 268 participants
Female
77
  55.4%
75
  58.1%
152
  56.7%
Male
62
  44.6%
54
  41.9%
116
  43.3%
[1]
Measure Description: All Randomized Patients with Moderate Disease [PGA = 2] at Baseline
Race/Ethnicity, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 139 participants 129 participants 268 participants
Caucasian 108 96 204
Black or African American 11 14 25
Asian (Indian) 1 2 3
Asian (Oriental) 1 3 4
Hispanic 16 11 27
Multi-racial/other 2 3 5
[1]
Measure Description: All Randomized Patients with Moderate Disease [PGA = 2] at Baseline
1.Primary Outcome
Title Percentage of Treatment Success Patients at Week 6, ITT (Intent to Treat) Population
Hide Description Treatment success defined as complete response (PGA score 0 and complete resolution of stool frequency, rectal bleeding, PFA (patient's functional assessment), normal sigmoidoscopy) or partial response (improvement from baseline PGA and improvement in 1 clinical assessment [stool frequency, rectal bleeding, PFA, sigmoidoscopy] and no worsening in any other clinical assessments)
Time Frame 6 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population with Moderate Disease [PGA = 2] at Baseline
Arm/Group Title Asacol 2.4 g/Day Asacol 4.8 g/Day
Hide Arm/Group Description:
Two 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg formulation) taken 3 times daily (morning, midday, evening).
Two 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg formulation) taken 3 times daily (morning, midday, evening).
Overall Number of Participants Analyzed 130 124
Measure Type: Number
Unit of Measure: Percentage of Participants
59.2 71.8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Asacol 2.4 g/Day, Asacol 4.8 g/Day
Comments It was assumed that true rate of improvement for 2.4 g/day treatment group is 40% and for the 4.8 g/day group is 60%. To detect a true difference of 20% between these 2 groups with 2-sided test, type I error of 0.05 (alpha = 0.05), and power of 80%, 120 patients with moderately active ulcerative colitis were required per group to complete the study.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0357
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Success Rates
Estimated Value 12.543
Confidence Interval (2-Sided) 95%
0.96 to 24.12
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in Ulcerative Colitis Disease Activity Index (UCDAI) at Week 6, ITT Population
Hide Description UCDAI - sum of clinical assessment scores (stool frequency score [0=normal, 1=1-2 stools > normal/day, 2=3-4 stools > normal/day, 3=5 or more stools > normal/day], rectal bleeding score [0=no blood seen, 1=streaks of blood with stool less than half of the time, 2=obvious blood with stool most of the time, 3=blood alone passed and PGA score [0=quiescent disease, 1=mild, 2=moderate, 3=severe]) and sigmoidoscopy score [0=normal, 1=mild, 2=moderate, 3=severe]
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population with Moderate Disease [PGA = 2] at Baseline.
Arm/Group Title Asacol 2.4 g/Day Asacol 4.8 g/Day
Hide Arm/Group Description:
Two 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg formulation) taken 3 times daily (morning, midday, evening).
Two 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg formulation) taken 3 times daily (morning, midday, evening).
Overall Number of Participants Analyzed 130 124
Mean (Standard Error)
Unit of Measure: Scores on a Scale
-3.2  (0.27) -3.7  (0.27)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Asacol 2.4 g/Day, Asacol 4.8 g/Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1594
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference Between Means
Estimated Value -0.5
Confidence Interval (2-Sided) 95%
-1.28 to 0.21
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Asacol 2.4 g/Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Compared to baseline
Method t-test, 2 sided
Comments The 2-sample t-test will be used to examine the treatment effect.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Asacol 4.8 g/Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Compared to baseline
Method t-test, 2 sided
Comments Teh 2-sample t-test will be used to examine the treatment effect.
3.Secondary Outcome
Title Percentage of Participants Whose Rectal Bleeding & Sigmoidoscopy Score Both Improved From Baseline to Week 6, ITT Population
Hide Description Rectal Bleeding - 0=no blood seen, 1=streaks of blood w/stool less than half of the time, 2=obvious blood w/stool most of the time, 3=blood alone passed Sigmoidoscopy Assessment Score - 0=normal (intact vascular pattern, no friability or granularity), 1=mild (erythema, diminished or absent vascular markings; mild granularity; friability), 2=moderate (marked erythema, granularity; absent vascular markings; bleeds with minimal trauma; no ulcerations) 3=severe (spontaneous bleeding, ulcerations)
Time Frame 6 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Patients with Moderate Disease [PGA=2] at Baseline. Percentage of patients whose rectal bleeding AND sigmoidoscopy scores BOTH improved from baseline at Week 6
Arm/Group Title Asacol 2.4 g/Day Asacol 4.8 g/Day
Hide Arm/Group Description:
Two 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg formulation) taken 3 times daily (morning, midday, evening).
Two 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg formulation) taken 3 times daily (morning, midday, evening).
Overall Number of Participants Analyzed 130 124
Measure Type: Number
Unit of Measure: Percentage of Participants
59.8 63.6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Asacol 2.4 g/Day, Asacol 4.8 g/Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5774
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Success Rates
Estimated Value 3.75
Confidence Interval (2-Sided) 95%
-9.43 to 16.93
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Percentage of Patients Whose Sigmoidoscopy Score Improved From Baseline to Week 6, ITT Population
Hide Description Sigmoidoscopy Assessment Score (0=normal intact vascular pattern, no friability or granularity, 1=mild erythema; diminished or absent vascular markings; mild granularity; friability, 2=moderate marked erythema, granularity; absent vascular markings; bleeds with minimal trauma; no ulcerations, 3=severe spontaneous bleeding, ulcerations)
Time Frame 6 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population with Moderate Disease [PGA=2] at Baseline
Arm/Group Title Asacol 2.4 g/Day Asacol 4.8 g/Day
Hide Arm/Group Description:
Two 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg formulation) taken 3 times daily (morning, midday, evening).
Two 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg formulation) taken 3 times daily (morning, midday, evening).
Overall Number of Participants Analyzed 130 124
Measure Type: Number
Unit of Measure: Percentage of Participants
69.0 75.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Asacol 2.4 g/Day, Asacol 4.8 g/Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2991
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Success Rates
Estimated Value 6.19
Confidence Interval (2-Sided) 95%
-5.47 to 17.86
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Percentage of Patients With an Improvement in Stool Frequency, ITT Population, Week 6
Hide Description 0=Normal stool frequency per day, 1=1-2 stools greater than normal per day, 2=3-4 stools greater than normal per day, 3=5 or more stools greater than normal per day
Time Frame 6 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Patients with Moderate Disease [PGA=2] at Baseline
Arm/Group Title Asacol 2.4 g/Day Asacol 4.8 g/Day
Hide Arm/Group Description:
Two 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg formulation) taken 3 times daily (morning, midday, evening).
Two 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg formulation) taken 3 times daily (morning, midday, evening).
Overall Number of Participants Analyzed 130 124
Measure Type: Number
Unit of Measure: Percentage of Participants
71.3 74.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Asacol 2.4 g/Day, Asacol 4.8 g/Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6543
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Success Rates
Estimated Value 2.74
Confidence Interval (2-Sided) 95%
-9.25 to 14.73
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Percentage of Patients With Improvement in Rectal Bleeding, ITT Population, Week 6
Hide Description Rectal Bleeding (0=no blood seen, 1=streaks of blood with stool less than half of the time, 2=obvious blood with stool most of the time, 3=blood alone passed)
Time Frame 6 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population with Moderate Disease [PGA=2] at Baseline
Arm/Group Title Asacol 2.4 g/Day Asacol 4.8 g/Day
Hide Arm/Group Description:
Two 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg formulation) taken 3 times daily (morning, midday, evening).
Two 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg formulation) taken 3 times daily (morning, midday, evening).
Overall Number of Participants Analyzed 130 124
Measure Type: Number
Unit of Measure: Percentage of Participants
77.5 78.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Asacol 2.4 g/Day, Asacol 4.8 g/Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8542
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Success Rates
Estimated Value 1.05
Confidence Interval (2-Sided) 95%
-10.19 to 12.29
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Percentage of Patients With Improvement in Patient's Functional Assessment (PFA), ITT Population, Week 6
Hide Description PFA - 0=generally well, 1=fair, 2=poor, 3=terrible
Time Frame 6 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population with Moderate Disease [PGA=2] at Baseline
Arm/Group Title Asacol 2.4 g/Day Asacol 4.8 g/Day
Hide Arm/Group Description:
Two 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg formulation) taken 3 times daily (morning, midday, evening).
Two 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg formulation) taken 3 times daily (morning, midday, evening).
Overall Number of Participants Analyzed 130 124
Measure Type: Number
Unit of Measure: Percentage of Participants
70.5 69.6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Asacol 2.4 g/Day, Asacol 4.8 g/Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8859
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Success Rates
Estimated Value -0.96
Confidence Interval (2-Sided) 95%
-14.09 to 12.17
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Percentage of Patients With Improvement in Physician Global Assessment (PGA)Score, ITT Population, Week 6
Hide Description PGA -Physician's Global Assessment - 0=quiescent disease (all parameters 0), 1=mild disease (parameters mostly 1's) 2=moderate (parameters mostly 2's), 3=severe (parameters mostly 3's) [parameters: combination of stool frequency, rectal bleeding, PFA & sigmoidoscopy findings] If scoring equal default to physician judgement.
Time Frame 6 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population with Moderate Disease [PGA=2] at Baseline
Arm/Group Title Asacol 2.4 g/Day Asacol 4.8 g/Day
Hide Arm/Group Description:
Two 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg formulation) taken 3 times daily (morning, midday, evening).
Two 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg formulation) taken 3 times daily (morning, midday, evening).
Overall Number of Participants Analyzed 130 124
Measure Type: Number
Unit of Measure: Percentage of Participants
73.5 83.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Asacol 2.4 g/Day, Asacol 4.8 g/Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0758
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Success Rates
Estimated Value 9.73
Confidence Interval (2-Sided) 95%
-0.94 to 20.40
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Mean Change From Baseline in Total Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 3, All Randomized Patients
Hide Description IBDQ-32 questions divided into 4 categories: bowel, systemic, emotional and social. Each question graded with the following responses: 1-more than ever before, 2-extremely frequently, 3-very frequently, 4-moderate increase in frequency, 5-some increase in frequency, 6-slight increase in frequency or 7-not at all/normal; 1/worst thru 7/best. Scoring 32 - 224 - higher score better.
Time Frame 3 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All Randomized Patients with Moderate Disease[PGA=2] at Baseline. Questionnaire analyzable if patient answered 28 of 32 for total, 8/10 for bowel, 3/5 for systemic, 10/12 for emotional, 3/5 for social.
Arm/Group Title Asacol 2.4 g/Day Asacol 4.8 g/Day
Hide Arm/Group Description:
Two 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg formulation) taken 3 times daily (morning, midday, evening).
Two 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg formulation) taken 3 times daily (morning, midday, evening).
Overall Number of Participants Analyzed 139 129
Mean (Standard Error)
Unit of Measure: Scores on a Scale
30.4  (2.84) 29.8  (2.60)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Asacol 2.4 g/Day, Asacol 4.8 g/Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8308
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Asacol 2.4 g/Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Compared to baseline
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Asacol 4.8 g/Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Compared to baseline.
Method t-test, 2 sided
Comments [Not Specified]
10.Secondary Outcome
Title Mean Change From Baseline in Total Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 6, All Randomized Patients
Hide Description IBDQ-32 questions divided into 4 categories: bowel, systemic, emotional and social. Each question graded with the following responses: 1-more than ever before, 2-extremely frequently, 3-very frequently, 4-moderate increase in frequency, 5-some increase in frequency, 6-slight increase in frequency or 7-not at all/normal; 1/worst thru 7/best. Scoring 32-224 - higher score better.
Time Frame 6 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All Randomized Patients with Moderate Disease [PGA=2] at Baseline. Questionnaire analyzable if patient answered 28 of 32 for total, 8/10 for bowel, 3/5 for systemic, 10/12 for emotional, 3/5 for social.
Arm/Group Title Asacol 2.4 g/Day Asacol 4.8 g/Day
Hide Arm/Group Description:
Two 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg formulation) taken 3 times daily (morning, midday, evening).
Two 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg formulation) taken 3 times daily (morning, midday, evening).
Overall Number of Participants Analyzed 139 129
Mean (Standard Error)
Unit of Measure: Scores on a Scale
43.1  (3.5) 40.4  (3.08)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Asacol 2.4 g/Day, Asacol 4.8 g/Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5340
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Asacol 2.4 g/Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Compared to baseline
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Asacol 4.8 g/Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Compared to baseline
Method t-test, 2 sided
Comments [Not Specified]
11.Secondary Outcome
Title Percentage of Patients With Moderate, Left-Sided Disease at Baseline Classified as Treatment Success at Week 6, All Randomized Patients
Hide Description Treatment success defined as complete response (PGA score 0 and complete resolution of stool frequency, rectal bleeding, PFA (patient's functional assessment), normal sigmoidoscopy) or partial response (improvement from baseline PGA and improvement in 1 clinical assessment [stool frequency, rectal bleeding, PFA, sigmoidoscopy] and no worsening in any other clinical assessments)
Time Frame 6 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All Randomized Patients with Moderate Disease [PGA=2] at Baseline. Left Sided Disease = proctitis, proctosigmoiditis or left-sided colitis
Arm/Group Title Asacol 2.4 g/Day Asacol 4.8 g/Day
Hide Arm/Group Description:
Two 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg formulation) taken 3 times daily (morning, midday, evening).
Two 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg formulation) taken 3 times daily (morning, midday, evening).
Overall Number of Participants Analyzed 105 97
Measure Type: Number
Unit of Measure: Percentage of Participants
60.0 71.1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Asacol 2.4 g/Day, Asacol 4.8 g/Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0966
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Success Rates
Estimated Value 11.1
Confidence Interval (2-Sided) 95%
-1.87 to 24.14
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Percentage of Treatment Success Patients at Week 3, ITT Population
Hide Description Treatment success defined as complete response (PGA score 0 and complete resolution of stool frequency, rectal bleeding, PFA (patient's functional assessment), normal sigmoidoscopy) or partial response (improvement from baseline PGA and improvement in 1 clinical assessment [stool frequency, rectal bleeding, PFA, sigmoidoscopy] and no worsening in any other clinical assessments)
Time Frame 3 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Patients with Moderate Disease [PGA = 2] at Baseline
Arm/Group Title Asacol 2.4 g/Day Asacol 4.8 g/Day
Hide Arm/Group Description:
Two 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg formulation) taken 3 times daily (morning, midday, evening).
Two 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg formulation) taken 3 times daily (morning, midday, evening).
Overall Number of Participants Analyzed 130 124
Measure Type: Number
Unit of Measure: Percentage of Participants
51.5 61.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Asacol 2.4 g/Day, Asacol 4.8 g/Day
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1173
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Success Rates
Estimated Value 9.75
Confidence Interval (2-Sided) 95%
-2.39 to 21.89
Estimation Comments [Not Specified]
Time Frame 6 week treatment period for each subject, February 28, 2001 thru April 15 2004
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Asacol 2.4 g/Day Asacol 4.8 g/Day
Hide Arm/Group Description Two 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg formulation) taken 3 times daily (morning, midday, evening). Two 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg formulation) taken 3 times daily (morning, midday, evening).
All-Cause Mortality
Asacol 2.4 g/Day Asacol 4.8 g/Day
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Asacol 2.4 g/Day Asacol 4.8 g/Day
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/139 (2.88%)      1/129 (0.78%)    
Cardiac disorders     
Pericarditis  1  0/139 (0.00%)  0 1/129 (0.78%)  1
Gastrointestinal disorders     
Nausea  1  1/139 (0.72%)  1 0/129 (0.00%)  0
Vomiting  1  1/139 (0.72%)  1 0/129 (0.00%)  0
Increased Diarrhea  1  1/139 (0.72%)  1 0/129 (0.00%)  0
Abdominal Cramping  1  1/139 (0.72%)  1 0/129 (0.00%)  0
Exacerbation of Ulcerative Colitis  1  1/139 (0.72%)  1 0/129 (0.00%)  0
Pancreatitis  1  1/139 (0.72%)  1 0/129 (0.00%)  0
Hepatobiliary disorders     
Cholecystitis  1  1/139 (0.72%)  1 0/129 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Shoulder/Chest Pain  1  0/139 (0.00%)  0 1/129 (0.78%)  1
Renal and urinary disorders     
Nephritis  1  1/139 (0.72%)  1 0/129 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, COSTART
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Asacol 2.4 g/Day Asacol 4.8 g/Day
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   72/195 (36.92%)      81/191 (42.41%)    
Gastrointestinal disorders     
Pain, Abdominal  1  11/195 (5.64%)  7/191 (3.66%) 
Diarrhea  1  6/195 (3.08%)  8/191 (4.19%) 
Nausea  1  5/195 (2.56%)  5/191 (2.62%) 
Rectal Disorder  1  5/195 (2.56%)  5/191 (2.62%) 
Dyspepsia  1  5/195 (2.56%)  4/191 (2.09%) 
Colitis Ulcer  1  3/195 (1.54%)  5/191 (2.62%) 
Flatulence  1  6/195 (3.08%)  2/191 (1.05%) 
General disorders     
Fever  1  4/195 (2.05%)  4/191 (2.09%) 
Asthenia  1  3/195 (1.54%)  4/191 (2.09%) 
Infections and infestations     
Infection  1  5/195 (2.56%)  9/191 (4.71%) 
Flu Syndrome  1  5/195 (2.56%)  4/191 (2.09%) 
Nervous system disorders     
Headache  1  15/195 (7.69%)  16/191 (8.38%) 
Respiratory, thoracic and mediastinal disorders     
Rhinitis  1  7/195 (3.59%)  1/191 (0.52%) 
Cough Increased  1  6/195 (3.08%)  1/191 (0.52%) 
Sinusitis  1  5/195 (2.56%)  1/191 (0.52%) 
Bronchitis  1  1/195 (0.51%)  4/191 (2.09%) 
Skin and subcutaneous tissue disorders     
Rash  1  4/195 (2.05%)  2/191 (1.05%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, COSTART
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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: Grexan Wulff, Manager Regulatory Affairs
Organization: Warner Chilcott
Phone: 973-442-3376
Responsible Party: Warner Chilcott
ClinicalTrials.gov Identifier: NCT00073021     History of Changes
Other Study ID Numbers: 2000082
First Submitted: November 13, 2003
First Posted: November 17, 2003
Results First Submitted: March 25, 2011
Results First Posted: July 28, 2011
Last Update Posted: June 29, 2015