Safety and Efficacy of Two Different Doses of Asacol in the Treatment of Moderately Active Ulcerative Colitis
- Conditions
- Ulcerative Colitis
- Interventions
- Registration Number
- NCT00073021
- Lead Sponsor
- Warner Chilcott
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 386
- male or female between 18 and 75 years of age;
- have a confirmed diagnosis of ulcerative colitis with the extent varying from proctitis to pancolitis;
- currently demonstrating moderately active disease
Patients will be excluded from admission to the study if they have/are:
- a history of allergy or hypersensitivity to salicylates or aminosalicylates;
- a history of extensive small bowel resection (>1/2 the length of the small intestine) causing short bowel syndrome;
- current renal or hepatic disease;
- participated in any drug or device clinical study within 30 days of entry;
- currently enrolled in any other clinical study;
- received any oral, intravenous, intramuscular, or rectally administered corticosteroids within 1 month prior to the Baseline Visit;
- received any other topical rectal therapy during the week prior to the Screening Visit;
- received immunomodulatory therapy including, but not limited to, 6-mercaptopurine, azathioprine, cyclosporine, or methotrexate within 3 months prior to the Baseline Visit;
- received a dose of mesalamine-containing compound by any route from which more than 1.6 g/day of mesalamine was available within 1 week prior to the Screening Visit (NOTE: 4 g/day of sulfasalazine and 4.5 g/day of balsalazide are equivalent to 1.6 g/day of mesalamine);
- received antibiotics, other than topical antibiotics, within 1 week prior to the Screening Visit;
- received aspirin (except for cardioprotective reasons up to a maximum dose of 325 mg/day) or NSAIDs within 1 week prior to the Baseline Visit;
- if female, positive pregnancy test, or lactating.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Asacol 2.4 g/day Asacol 400 mg (mesalamine) Asacol (2.4 g/day) Asacol 4.8 g/day Asacol 800 mg (mesalamine) Asacol (4.8 g/day)
- Primary Outcome Measures
Name Time Method Percentage of Treatment Success Patients at Week 6, ITT (Intent to Treat) Population 6 Weeks 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)
- Secondary Outcome Measures
Name Time Method Change From Baseline in Ulcerative Colitis Disease Activity Index (UCDAI) at Week 6, ITT Population 6 weeks 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 \[0=normal, 1=mild, 2=moderate, 3=severe\]
Percentage of Participants Whose Rectal Bleeding & Sigmoidoscopy Score Both Improved From Baseline to Week 6, ITT Population 6 Weeks 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)
Percentage of Patients Whose Sigmoidoscopy Score Improved From Baseline to Week 6, ITT Population 6 Weeks 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)
Percentage of Patients With an Improvement in Stool Frequency, ITT Population, Week 6 6 Weeks 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
Percentage of Patients With Improvement in Rectal Bleeding, ITT Population, Week 6 6 Weeks 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)
Percentage of Patients With Improvement in Patient's Functional Assessment (PFA), ITT Population, Week 6 6 Weeks PFA - 0=generally well, 1=fair, 2=poor, 3=terrible
Percentage of Patients With Improvement in Physician Global Assessment (PGA)Score, ITT Population, Week 6 6 Weeks 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.
Mean Change From Baseline in Total Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 3, All Randomized Patients 3 Weeks 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.
Mean Change From Baseline in Total Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 6, All Randomized Patients 6 Weeks 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.
Percentage of Patients With Moderate, Left-Sided Disease at Baseline Classified as Treatment Success at Week 6, All Randomized Patients 6 Weeks 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)
Percentage of Treatment Success Patients at Week 3, ITT Population 3 Weeks 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)
Trial Locations
- Locations (30)
University of Chicago Medical Center
🇺🇸Chicago, Illinois, United States
Louisiana Research Center
🇺🇸Shreveport, Louisiana, United States
Long Island Clinical Research Associates
🇺🇸Great Neck, New York, United States
Center for Medical Research, LLC
🇺🇸Manchester, Connecticut, United States
Center for GI Disorders
🇺🇸Hollywood, Florida, United States
AGMG Clinical Research
🇺🇸Orange, California, United States
Research Site
🇨🇦Toronto, Ontario, Canada
Community Clinical Trials
🇺🇸Orange, California, United States
Carolinas Digestive Health Associates
🇺🇸Charlotte, North Carolina, United States
Advanced Gastroenterology Associates
🇺🇸Palm Harbor, Florida, United States
Southeast Research Associates
🇺🇸Marietta, Georgia, United States
Digestive Disease Associates
🇺🇸Baltimore, Maryland, United States
Regional Research Institute
🇺🇸Jackson, Tennessee, United States
Mayo Clinic Scottsdale
🇺🇸Scottsdale, Arizona, United States
Digestive Disorders Associates
🇺🇸Annapolis, Maryland, United States
PharmaTrials, Inc.
🇺🇸Hillsborough, New Jersey, United States
Richmond GI Research
🇺🇸Richmond, Virginia, United States
University of Puerto Rico, School of Medicine
🇵🇷San Juan, Puerto Rico
Charlottesville Medical Research
🇺🇸Charlottesville, Virginia, United States
GI & Liver Consultants
🇺🇸Dayton, Ohio, United States
Brigham & Women's Hospital
🇺🇸Boston, Massachusetts, United States
Sharp Rees-Stealy Medical Group
🇺🇸San Diego, California, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Wisconsin Center for Advanced Research
🇺🇸Milwaukee, Wisconsin, United States
Consultants for Clinical Research
🇺🇸Cincinnati, Ohio, United States
West Hills Gastroenterology Group
🇺🇸Portland, Oregon, United States
Houston Medical Research Associates
🇺🇸Houston, Texas, United States
Metropolitan Gastroenterology Group
🇺🇸Chevy Chase, Maryland, United States
GI Research
🇺🇸Metairie, Louisiana, United States