The purpose of this study is to evaluate the safety and efficacy of Asacol 4.8 g/day (800 mg tablet) versus Asacol 2.4 g/day (400 mg tablet
This study is designed to evaluate the safety and efficacy of 4.8 g/day using 800 mg Asacol tablets as compared to 2.4g/day using 400 mg Asacol tablets in newly- and previously-diagnosed patients who are experiencing a flare-up of mildly to moderately active ulcerative colitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
301
mesalamine 2.4 g/day (400 mg tablet) for 6 weeks
mesalamine 4.8 g/day (800 mg tablet) for 6 weeks
Percentage of Patients Classified as Treatment Success at Week 6, ITT Population
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
Percentage of Patients Classified as Treatment Success at Week 3, ITT Population
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
Physician's Global Assessment (PGA) Percentage of Patients Improved at Week 3, All Randomized Patients
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
Physician's Global Assessment (PGA) Percentage of Patients Improved at Week 6, All Randomized Patients
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.
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Research Site
Birmingham, Alabama, United States
Research Site
Anaheim, California, United States
Research Site
Sacramento, California, United States
Research Site
San Francisco, California, United States
Research Site
Denver, Colorado, United States
Research Facility
Golden, Colorado, United States
Research Site
Bridgeport, Connecticut, United States
Research Site
Fort Myers, Florida, United States
Research Site
Hollywood, Florida, United States
Research Site
Jupiter, Florida, United States
...and 34 more locations
Time frame: Week 6
Stool Frequency Improvement at Week 3, All Randomized Patients (Percentage)
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
Stool Frequency Improvement at Week 6, All Randomized Patients (Percentage)
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
Rectal Bleeding Improvement at Week 3, All Randomized Patients (Percentage)
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
Rectal Bleeding Improvement at Week 6, All Randomized Patients (Percentage)
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
Improvement in Patient's Functional Assessment (PFA) at Week 3, All Randomized Patients (Percentage)
0-generally well, 1-fair, 2-poor, 3-terrible
Time frame: Week 3
Improvement in Patient's Functional Assessment (PFA) at Week 6, All Randomized Patients (Percentage)
0-generally well, 1-fair, 2-poor, 3-terrible
Time frame: Week 6
Improvement in Patient's Sigmoidoscopy Assessment Score at Week 3, All Randomized Patients (Percentage)
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
Improvement in Patient's Sigmoidoscopy Assessment Score at Week 6, All Randomized Patients (Percentage)
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