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

• Percentage of Patients Classified as Treatment Success at Week 6, ITT Population [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
  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.
  
  

• Percentage of Patients Classified as Treatment Success at Week 3, ITT Population [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
  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.
  
  
• Physician's Global Assessment (PGA) Percentage of Patients Improved at Week 3, All Randomized Patients [ Time Frame: Week 3 ] [ Designated as safety issue: No ]
  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.
  
  
• Physician's Global Assessment (PGA) Percentage of Patients Improved at Week 6, All Randomized Patients [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
  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.
  
  
• Stool Frequency Improvement at Week 3, All Randomized Patients (Percentage) [ Time Frame: Week 3 ] [ Designated as safety issue: No ]
  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.
  
  
• Stool Frequency Improvement at Week 6, All Randomized Patients (Percentage) [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
  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.
  
  
• Rectal Bleeding Improvement at Week 3, All Randomized Patients (Percentage) [ Time Frame: Week 3 ] [ Designated as safety issue: No ]
  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.
  
  
• Rectal Bleeding Improvement at Week 6, All Randomized Patients (Percentage) [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
  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.
  
  
• Improvement in Patient's Functional Assessment (PFA) at Week 3, All Randomized Patients (Percentage) [ Time Frame: Week 3 ] [ Designated as safety issue: No ]
  0-generally well, 1-fair, 2-poor, 3-terrible
  
  
• Improvement in Patient's Functional Assessment (PFA) at Week 6, All Randomized Patients (Percentage) [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
  0-generally well, 1-fair, 2-poor, 3-terrible
  
  
• Improvement in Patient's Sigmoidoscopy Assessment Score at Week 3, All Randomized Patients (Percentage) [ Time Frame: Week 3 ] [ Designated as safety issue: No ]
  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.
  
  
• Improvement in Patient's Sigmoidoscopy Assessment Score at Week 6, All Randomized Patients (Percentage) [ Time Frame: Week 6 ] [ Designated as safety issue: No ]
  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.
  
  

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.