Safety and Efficacy of Asacol 4.8 g/Day Versus Asacol 2.4 g/Day (ASCEND I)
- Registration Number
- NCT00577473
- Lead Sponsor
- Warner Chilcott
- Brief Summary
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
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 301
- confirmed diagnosis of ulcerative colitis
- a history of allergy or hypersensitivity to salicylates or aminosalicylates;
- a history of extensive small bowel resection
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 mesalamine mesalamine 4.8 g/day (800 mg tablet) for 6 weeks 1 mesalamine mesalamine 2.4 g/day (400 mg tablet) for 6 weeks
- Primary Outcome Measures
Name Time Method Percentage of Patients Classified as Treatment Success at Week 6, ITT Population 6 weeks 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.
- Secondary Outcome Measures
Name Time Method Percentage of Patients Classified as Treatment Success at Week 3, ITT Population 3 weeks 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 Week 3 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 Week 6 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) Week 3 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) 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, Scoring Scale: 0-good thru 3-worse.
Rectal Bleeding Improvement at Week 3, All Randomized Patients (Percentage) Week 3 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) Week 6 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) Week 3 0-generally well, 1-fair, 2-poor, 3-terrible
Improvement in Patient's Functional Assessment (PFA) at Week 6, All Randomized Patients (Percentage) Week 6 0-generally well, 1-fair, 2-poor, 3-terrible
Improvement in Patient's Sigmoidoscopy Assessment Score at Week 3, All Randomized Patients (Percentage) Week 3 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) Week 6 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.
Trial Locations
- Locations (2)
Research Site
🇺🇸Milwaukee, Wisconsin, United States
Research Facility
🇺🇸Falls Church, Virginia, United States