This study is a prospective clinical study to evaluate the safety and efficacy of two different doses of Asacol for the treatment of moderately active ulcerative colitis. In addition, a new tablet formulation will be evaluated at one of the two doses.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
386
tablets, 4.8 g/day for 6 weeks, 2 - 800 mg Asacol tablets and 2 placebo tablets 3 times daily
tablets, 2.4 g/day for 6 weeks, 2 - 400 mg Asacol tablets and 2 placebo tablets 3 times daily
Percentage of Treatment Success Patients at Week 6, ITT (Intent to Treat) Population
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
Change From Baseline in Ulcerative Colitis Disease Activity Index (UCDAI) at Week 6, ITT Population
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
Percentage of Participants Whose Rectal Bleeding & Sigmoidoscopy Score Both Improved From Baseline to Week 6, ITT Population
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
Percentage of Patients Whose Sigmoidoscopy Score Improved From Baseline to Week 6, ITT Population
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)
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Mayo Clinic Scottsdale
Scottsdale, Arizona, United States
AGMG Clinical Research
Anaheim, California, United States
Research Site
Los Angeles, California, United States
Community Clinical Trials
Orange, California, United States
AGMG Clinical Research
Orange, California, United States
Research Site
Sacramento, California, United States
Sharp Rees-Stealy Medical Group
San Diego, California, United States
Research Site
Arvada, Colorado, United States
Research Site
Englewood, Colorado, United States
Center for Medical Research, LLC
Manchester, Connecticut, United States
...and 47 more locations
Time frame: 6 Weeks
Percentage of Patients With an Improvement in Stool Frequency, ITT Population, Week 6
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
Percentage of Patients With Improvement in Rectal Bleeding, ITT Population, Week 6
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
Percentage of Patients With Improvement in Patient's Functional Assessment (PFA), ITT Population, Week 6
PFA - 0=generally well, 1=fair, 2=poor, 3=terrible
Time frame: 6 Weeks
Percentage of Patients With Improvement in Physician Global Assessment (PGA)Score, ITT Population, Week 6
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
Mean Change From Baseline in Total Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 3, All Randomized Patients
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
Mean Change From Baseline in Total Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 6, All Randomized Patients
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
Percentage of Patients With Moderate, Left-Sided Disease at Baseline Classified as Treatment Success at Week 6, All Randomized Patients
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
Percentage of Treatment Success Patients at Week 3, ITT Population
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