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Safety and Efficacy of Asacol 4.8 g/Day Versus Asacol 2.4 g/Day (ASCEND I) (ASCEND I)

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ClinicalTrials.gov Identifier: NCT00577473
Recruitment Status : Completed
First Posted : December 20, 2007
Results First Posted : June 22, 2011
Last Update Posted : September 16, 2011
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
Intervention Drug: mesalamine
Enrollment 301
Recruitment Details Screening began 9 Feb 2001
Pre-assignment Details  
Arm/Group Title Asacol 2.4 g/Day Asacol 4.8 g/Day
Hide Arm/Group Description 2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks 2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
Period Title: Overall Study
Started 154 147
ITT Population 150 136
Completed 133 123
Not Completed 21 24
Reason Not Completed
Protocol Violation             1             4
Adverse Event             8             5
Withdrawal by Subject             2             6
Physician Decision             2             2
Lack of Efficacy             8             7
Arm/Group Title Asacol 2.4 g/Day Asacol 4.8 g/Day Total
Hide Arm/Group Description 2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks 2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks Total of all reporting groups
Overall Number of Baseline Participants 154 147 301
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 154 participants 147 participants 301 participants
18 - 64 years 141 133 274
>= 65 years 13 14 27
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 154 participants 147 participants 301 participants
Female
79
  51.3%
67
  45.6%
146
  48.5%
Male
75
  48.7%
80
  54.4%
155
  51.5%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Partcipants
Number Analyzed 154 participants 147 participants 301 participants
Caucasian 122 116 238
Black or African American 18 18 36
Asian (Indian) 2 2 4
Asian (Oriental) 1 0 1
Hispanic 10 9 19
Multi-racial/other 1 2 3
1.Primary Outcome
Title Percentage of Patients Classified as Treatment Success at Week 6, ITT Population
Hide Description Treatment Success - complete or partial response; Complete = complete resolution of clinical assessments (stool frequency, rectal bleeding, PFA [patient's functional assessment], sigmoidoscopy) and PGA (physician global assessment) = 0, Partial = improvement from baseline PGA score and improvement in at least 1 of the clinical assessments [decrease of at least 1 on scale] and no worsening [no score increases] of remaining clinical assessments. Each clinical assessment graded using scale 0/normal, better thru 3/severe, worse.
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Asacol 2.4 g/Day Asacol 4.8 g/Day
Hide Arm/Group Description:
2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks
2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
Overall Number of Participants Analyzed 150 136
Measure Type: Number
Unit of Measure: Percentage of Participants
51.3 55.9
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 the true rate of improvement for the 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 a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4411
Comments 4.8 g/day compared to 2.4 g/day
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.0455
Confidence Interval (2-Sided) 95%
-7.01 to 16.11
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Patients Classified as Treatment Success at Week 3, ITT Population
Hide Description Treatment Success - complete or partial response; Complete = complete resolution of clinical assessments (stool frequency, rectal bleeding, PFA [patient's functional assessment], sigmoidoscopy) and PGA (physician global assessment) = 0, Partial = improvement from baseline PGA score and improvement in at least 1 of the clinical assessments [decrease of at least 1 on scale] and no worsening [no score increases] of remaining clinical assessments. Each clinical assessment graded using scale 0/normal, better thru 3/severe, worse.
Time Frame 3 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Asacol 2.4 g/Day Asacol 4.8 g/Day
Hide Arm/Group Description:
2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks
2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
Overall Number of Participants Analyzed 150 137
Measure Type: Number
Unit of Measure: Percentage of Participants
42.0 38.7
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 the true rate of improvement for the 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 a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5677
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.0331
Confidence Interval (2-Sided) 95%
-14.67 to 8.04
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Physician's Global Assessment (PGA) Percentage of Patients Improved at Week 3, All Randomized Patients
Hide Description PGA - 0-quiescent disease activity (all 0's) , 1-mild (mostly 1's), 2-moderate (mostly 2's), 3-severe (mostly 3's) based upon on scoring for stool frequency, rectal bleeding, PFR (patient's functional assessment - 0-well, 1-fair, 2-poor, 3-terrible), sigmoidoscopy findings. Improvement defined as either complete response (remission, score = 0) or partial response (improvement on treatment). Scoring Scale: 0-good thru 3-worse.
Time Frame Week 3
Hide Outcome Measure Data
Hide Analysis Population Description
All Randomized Patients
Arm/Group Title Asacol 2.4 g/Day Asacol 4.8 g/Day
Hide Arm/Group Description:
2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks
2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
Overall Number of Participants Analyzed 154 147
Measure Type: Number
Unit of Measure: Percentage of Participants
49.3 44.8
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 the true rate of improvement for the 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 a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4730
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.0445
Confidence Interval (2-Sided) 95%
-16.6 to 7.7
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Physician's Global Assessment (PGA) Percentage of Patients Improved at Week 6, All Randomized Patients
Hide Description PGA - 0-quiescent disease activity (all 0's) , 1-mild (mostly 1's), 2-moderate (mostly 2's), 3-severe (mostly 3's) based upon on scoring for stool frequency, rectal bleeding, PFR (patient's functional assessment - 0-well, 1-fair, 2-poor, 3-terrible), sigmoidoscopy findings. Improvement defined as complete response (remission, score = 0) or partial response (improvement on treatment). Scoring Scale: 0-good thru 3-worse.
Time Frame Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
All Randomized Patients
Arm/Group Title Asacol 2.4 g/Day Asacol 4.8 g/Day
Hide Arm/Group Description:
2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks
2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
Overall Number of Participants Analyzed 154 147
Measure Type: Number
Unit of Measure: Percentage of Participants
61.4 64.8
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 the true rate of improvement for the 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 a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5761
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.0339
Confidence Interval (2-Sided) 95%
-8.48 to 15.26
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Stool Frequency Improvement at Week 3, All Randomized Patients (Percentage)
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, Scoring Scale: 0-good thru 3-worse.
Time Frame Week 3
Hide Outcome Measure Data
Hide Analysis Population Description
All Randomized Patients
Arm/Group Title Asacol 2.4 g/Day Asacol 4.8 g/Day
Hide Arm/Group Description:
2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks
2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
Overall Number of Participants Analyzed 154 147
Measure Type: Number
Unit of Measure: Percentage of Participants
46.7 54.3
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 It was assumed that the true rate of improvement for the 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 a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2150
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.0766
Confidence Interval (2-Sided) 95%
-4.41 to 19.74
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Stool Frequency Improvement at Week 6, All Randomized Patients (Percentage)
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, Scoring Scale: 0-good thru 3-worse.
Time Frame Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
All Randomized Patients
Arm/Group Title Asacol 2.4 g/Day Asacol 4.8 g/Day
Hide Arm/Group Description:
2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks
2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
Overall Number of Participants Analyzed 154 147
Measure Type: Number
Unit of Measure: Percentage of Participants
63.2 66.7
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 the true rate of improvement for the 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 a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5569
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.0351
Confidence Interval (2-Sided) 95%
-8.18 to 15.20
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Rectal Bleeding Improvement at Week 3, All Randomized Patients (Percentage)
Hide Description 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, Scoring Scale: 0-good thru 3-worse.
Time Frame Week 3
Hide Outcome Measure Data
Hide Analysis Population Description
All Randomized Patients
Arm/Group Title Asacol 2.4 g/Day Asacol 4.8 g/Day
Hide Arm/Group Description:
2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks
2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
Overall Number of Participants Analyzed 154 147
Measure Type: Number
Unit of Measure: Percentage of Participants
48.1 59.1
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 It was assumed that the true rate of improvement for the 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 a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0769
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.1091
Confidence Interval (2-Sided) 95%
-1.10 to 22.91
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Rectal Bleeding Improvement at Week 6, All Randomized Patients (Percentage)
Hide Description 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. Scoring Scale: 0-good thru 3-worse.
Time Frame Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
All Randomized Patients
Arm/Group Title Asacol 2.4 g/Day Asacol 4.8 g/Day
Hide Arm/Group Description:
2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks
2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
Overall Number of Participants Analyzed 154 147
Measure Type: Number
Unit of Measure: Percentage of Participants
60.2 71.5
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 It was assumed that the true rate of improvement for the 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 a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0551
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.1139
Confidence Interval (2-Sided) 95%
-0.13 to 22.92
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Improvement in Patient's Functional Assessment (PFA) at Week 3, All Randomized Patients (Percentage)
Hide Description 0-generally well, 1-fair, 2-poor, 3-terrible
Time Frame Week 3
Hide Outcome Measure Data
Hide Analysis Population Description
All Randomized Patients
Arm/Group Title Asacol 2.4 g/Day Asacol 4.8 g/Day
Hide Arm/Group Description:
2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks
2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
Overall Number of Participants Analyzed 154 147
Measure Type: Number
Unit of Measure: Percentage of Participants
42.2 49.6
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 It was assumed that the true rate of improvement for the 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 a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2306
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.0738
Confidence Interval (2-Sided) 95%
-4.66 to 19.43
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Improvement in Patient's Functional Assessment (PFA) at Week 6, All Randomized Patients (Percentage)
Hide Description 0-generally well, 1-fair, 2-poor, 3-terrible
Time Frame Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
All Randomized Patients
Arm/Group Title Asacol 2.4 g/Day Asacol 4.8 g/Day
Hide Arm/Group Description:
2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks
2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
Overall Number of Participants Analyzed 154 147
Measure Type: Number
Unit of Measure: Percentage of Participants
54.1 60.7
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 the true rate of improvement for the 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 a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2931
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.0652
Confidence Interval (2-Sided) 95%
-5.60 to 18.64
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Improvement in Patient's Sigmoidoscopy Assessment Score at Week 3, All Randomized Patients (Percentage)
Hide Description 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). Scoring Scale: 0-good thru 3-worse.
Time Frame Week 3
Hide Outcome Measure Data
Hide Analysis Population Description
All Randomized Patients
Arm/Group Title Asacol 2.4 g/Day Asacol 4.8 g/Day
Hide Arm/Group Description:
2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks
2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
Overall Number of Participants Analyzed 154 147
Measure Type: Number
Unit of Measure: Percentage of Participants
51.5 52.0
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 It was assumed that the true rate of improvement for the 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 a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9349
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.0051
Confidence Interval (2-Sided) 95%
-11.67 to 12.69
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Improvement in Patient's Sigmoidoscopy Assessment Score at Week 6, All Randomized Patients (Percentage)
Hide Description 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). Scoring Scale: 0-good thru 3-worse.
Time Frame Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
All Randomized Patients
Arm/Group Title Asacol 2.4 g/Day Asacol 4.8 g/Day
Hide Arm/Group Description:
2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks
2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
Overall Number of Participants Analyzed 154 147
Measure Type: Number
Unit of Measure: Percentage of Participants
66.7 73.2
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 It was assumed that the true rate of improvement for the 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 a 2-sided test, type I error of 0.05 (α = 0.05), and power of 90%, 140 patients were required per group to complete the study. To account for a 10% dropout/withdrawal rate, approximately 308 patients were to be enrolled in the study.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2583
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.0650
Confidence Interval (2-Sided) 95%
-4.72 to 17.73
Estimation Comments [Not Specified]
Time Frame 6 week treatment period
Adverse Event Reporting Description Screening started February 2001, study completed November 2002
 
Arm/Group Title Asacol 2.4 g/Day Asacol 4.8 g/Day
Hide Arm/Group Description 2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks 2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
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   3/154 (1.95%)      1/147 (0.68%)    
Gastrointestinal disorders     
Worsening of Ulcerative Colitis  1  1/154 (0.65%)  1 0/147 (0.00%)  0
Rectal Bleeding  1  1/154 (0.65%)  1 0/147 (0.00%)  0
Diarrhea  1  1/154 (0.65%)  1 0/147 (0.00%)  0
Cholecystitis  1  1/154 (0.65%)  1 0/147 (0.00%)  0
Nervous system disorders     
Pain, Right Upper Quadrant  1  1/154 (0.65%)  1 0/147 (0.00%)  0
Epigastric Pain  1  0/154 (0.00%)  0 1/147 (0.68%)  1
Reproductive system and breast disorders     
Uterine Fibroids Exacerbation  1  1/154 (0.65%)  1 0/147 (0.00%)  0
Ovarian Cyst Exacerbation  1  1/154 (0.65%)  1 0/147 (0.00%)  0
Vascular disorders     
Abdominal Pain, Left Side  1  1/154 (0.65%)  1 0/147 (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   56/154 (36.36%)      48/147 (32.65%)    
Gastrointestinal disorders     
Nausea  1  2/154 (1.30%)  9/147 (6.12%) 
Abdominal Pain  1  7/154 (4.55%)  4/147 (2.72%) 
Diarrhea  1  5/154 (3.25%)  4/147 (2.72%) 
Flatulence  1  3/154 (1.95%)  6/147 (4.08%) 
Colitis Ulcer  1  6/154 (3.90%)  2/147 (1.36%) 
Vomiting  1  1/154 (0.65%)  6/147 (4.08%) 
Dyspepsia  1  2/154 (1.30%)  3/147 (2.04%) 
Infections and infestations     
Infection  1  5/154 (3.25%)  5/147 (3.40%) 
Flu Syndrome  1  5/154 (3.25%)  0/147 (0.00%) 
Nervous system disorders     
Headache  1  9/154 (5.84%)  8/147 (5.44%) 
Dizziness  1  4/154 (2.60%)  1/147 (0.68%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  4/154 (2.60%)  1/147 (0.68%) 
Skin and subcutaneous tissue disorders     
Rash  1  3/154 (1.95%)  3/147 (2.04%) 
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: NCT00577473     History of Changes
Other Study ID Numbers: 2000083
First Submitted: December 19, 2007
First Posted: December 20, 2007
Results First Submitted: May 24, 2011
Results First Posted: June 22, 2011
Last Update Posted: September 16, 2011