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.

Condition	Treatment or Intervention	Phase
Ulcerative Colitis	Drug: Asacol (mesalamine)	Phase III

Ages Eligible for Study:  18 Years   -   75 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

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 pregancy test, or lactating.

Arizona
      Mayo Clinic Scottsdale, Scottsdale,  Arizona,  85259,  United States
California
      AGMG Clinical Research, Orange,  California,  92869,  United States
      Sharp Rees-Stealy Medical Group, San Diego,  California,  92123,  United States
      AGMG Clinical Research, Anaheim,  California,  92801,  United States
      Community Clinical Trials, Orange,  California,  38305,  United States
Connecticut
      Center for Medical Research, LLC, Manchester,  Connecticut,  6040,  United States
Florida
      Center for GI Disorders, Hollywood,  Florida,  33021,  United States
      Advanced Gastroenterology Associates, Palm Harbor,  Florida,  34684,  United States
Georgia
      Southeast Research Associates, Marietta,  Georgia,  30067,  United States
Illinois
      University of Chicago Medical Center, Chicago,  Illinois,  60637,  United States
Louisiana
      Louisiana Research Center, Shreveport,  Louisiana,  71103,  United States
      GI Research, Metairie,  Louisiana,  70001,  United States
Maryland
      Digestive Disorders Associates, Annapolis,  Maryland,  21401,  United States
      Metropolitan Gastroenterology Group, Chevy Chase,  Maryland,  20815,  United States
      Digestive Disease Associates, Baltimore,  Maryland,  21229,  United States
Massachusetts
      Brigham & Women's Hospital, Boston,  Massachusetts,  2115,  United States
Michigan
      Henry Ford Hospital, Detroit,  Michigan,  48202,  United States
Minnesota
      Mayo Clinic, Rochester,  Minnesota,  55905,  United States
New Jersey
      PharmaTrials, Inc., Hillsborough,  New Jersey,  08844,  United States
New York
      Long Island Clinical Research Associates, Great Neck,  New York,  11021,  United States
North Carolina
      Carolinas Digestive Health Associates, Charlotte,  North Carolina,  28262,  United States
Ohio
      Consultants for Clinical Research, Cincinnati,  Ohio,  45219,  United States
      GI & Liver Consultants, Dayton,  Ohio,  45440,  United States
Oregon
      West Hills Gastroenterology Group, Portland,  Oregon,  97225,  United States
Tennessee
      Regional Research Institute, Jackson,  Tennessee,  38305,  United States
Texas
      Houston Medical Research Associates, Houston,  Texas,  77090,  United States
Virginia
      Charlottesville Medical Research, Charlottesville,  Virginia,  22902,  United States
      Richmond GI Research, Richmond,  Virginia,  23226,  United States
Wisconsin
      Wisconsin Center for Advanced Research, Milwaukee,  Wisconsin,  53207,  United States
Puerto Rico
      University of Puerto Rico, School of Medicine, San Juan,  00935,  Puerto Rico

Study ID Numbers:  200082
Record last reviewed:  March 2004
Last Updated:  October 25, 2004
Record first received:  November 13, 2003
ClinicalTrials.gov Identifier:  NCT00073021
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08