This dose comparison study, taking place at over 200 sites worldwide, will compare the dosing, safety and efficacy of an investigational medicine OPC-6535 to the dosing, safety and efficacy of Asacol ® in the maintenance of remission in subjects with ulcerative colitis.

Condition	Treatment or Intervention	Phase
Ulcerative Colitis	Drug: OPC-6535  Drug: Asacol®	Phase III

Further Study Details: 

Expected Total Enrollment:  1725

Objective(s): This study will compare the safety and efficacy of 25 mg per day (QD) and 50 mg QD of OPC-6535 to 800 mg twice a day (BID) of Asacol® in the maintenance of remission in subjects with ulcerative colitis.

Subject Population: • Subjects with ulcerative colitis currently in remission defined as rectal bleeding (RB) and flexible sigmoidoscopy (FS) scores of 0, on or off a stable dose of sulfasalazine or 5-ASA products for at least 6 weeks. • Subjects must have had the diagnosis of ulcerative colitis established by prior colonoscopy or undergo colonoscopy in lieu of flexible sigmoidoscopy during the Screening Period. • Subjects must have had treatment for a flare of ulcerative colitis, with symptomatic onset of remission occurring no more than 52 weeks from the Screening Period. • Subjects may not have used corticosteroids, topical agents (corticosteroid or 5-ASA enemas, suppositories, foams), azathioprine, 6-mercaptopurine, or methotrexate within 6 weeks of the Screening Period. Upon entry, sulfasalazine and 5-ASA containing products will be discontinued.

Safety: Vital signs, ECGs, laboratory studies (including hematology, clinical chemistry, and urinalysis), and adverse events.

Ages Eligible for Study:  18 Years   -   80 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Male or female subjects, 18 to 80 years of age, inclusive.
• Subjects with a prior diagnosis of ulcerative colitis, established by colonoscopy.
• Subjects currently in remission.
• Subjects who have undergone treatment for a flare of ulcerative colitis, with symptomatic onset of remission occurring no more than 52 weeks from the Screening Period.
• If subjects are taking sulfasalazine or 5-ASA products prior to entry, the dose must be stable for at least 6 weeks prior to the Screening Period. NOTE: During the study, use of these drugs will be discontinued.
• Subjects having undergone colonoscopy with pan-colonic surveillance biopsies negative for dysplasia within 1 year of the Screening Visit if at increased risk of colorectal cancer (≥ 8 year history of ulcerative colitis).
• Female or male subjects who are surgically sterilized or who are prepared to and agree to practice a double-barrier form of birth control from the Screening Period through 30 days (females) and 90 days (males), respectively, from the last dose of study medication. Females who are more than 12 months post-menopausal are also eligible to participate in the study.

Exclusion Criteria:

• Subjects who have active disease.
• Subjects who have any other clinically significant disease(s) or condition/procedure(s).
• Subjects who have had major gastrointestinal surgery including, but not limited to, a colostomy, an ileostomy or previous colonic surgery other than appendectomy.
• Subjects who have used corticosteroids or topical agents (corticosteroid or 5-ASA enemas, suppositories, foams) within 6 weeks of the Screening Period.
• Female subjects who are pregnant or lactating.
• Other exclusion criteria may apply.

CORE Call Center      1-866-707-8839    info@colitistrial.com

Alabama
      Clinical Research Associates, Huntsville,  Alabama,  35801,  United States; Recruiting
Arizona
      Advanced Clinical Therapeutics, Tucson,  Arizona,  85714,  United States; Recruiting
California
      Associated Gastroenterology Medical Group, Orange,  California,  92869,  United States; Recruiting
      Lovelace Scientific Resources, Santa Ana,  California,  92704,  United States; Recruiting
      West Gastroenterology Medical Group, Los Angeles,  California,  90045,  United States; Recruiting
      Sharp Rees-Stealy Medical Group, San Diego,  California,  92123,  United States; Recruiting
      Clinical Applications Labratories, San Diego,  California,  92103,  United States; Recruiting
      Medical Associates Research Group, San Diego,  California,  92123,  United States; Recruiting
      Medical Research Centers of California, Inc., Fresno,  California,  93720,  United States; Recruiting
      David Stanton, Orange,  California,  92868,  United States; Recruiting
Colorado
      Western States Clinical Research, Wheat Ridge,  Colorado,  80033,  United States; Recruiting
Connecticut
      Gastroenterology Associates, LLC, Torrington,  Connecticut,  06790,  United States; Recruiting
      America's Doctor, Bridgeport,  Connecticut,  06606,  United States; Recruiting
District of Columbia
      George Washington University, Washington,  District of Columbia,  20037,  United States; Recruiting
Florida
      Venture Research Institute, LLC, N. Miami Beach,  Florida,  33162,  United States; Recruiting
      Borland-Groover Clinic, Jacksonville,  Florida,  32256,  United States; Recruiting
      nTouch Research, Melbourne,  Florida,  32901,  United States; Recruiting
      Gastroenterology Consultants, PA, Ormond Beach,  Florida,  32174,  United States; Recruiting
      Miami Research Associates, Miami,  Florida,  33173,  United States; Recruiting
      Advanced Gastroenterology Associates, Palm Harbor,  Florida,  34684,  United States; Recruiting
      Mark Lamet, Hollywood,  Florida,  33021,  United States; Recruiting
      OMNI Healthcare, Melbourne,  Florida,  32901,  United States; Recruiting
      Florida Medical Clinic, Zyphyrhills,  Florida,  33542,  United States; Recruiting
      The Ford Research Institute, Pensacola,  Florida,  32514,  United States; Recruiting
      Lovelace Scientific Resources, Miami,  Florida,  33156,  United States; Recruiting
Georgia
      Atlantic Gastroenterology, Atlanta,  Georgia,  United States; Recruiting
      nTouch Research, Decatur,  Georgia,  30033,  United States; Recruiting
      America's Doctor, Savannah,  Georgia,  31404,  United States; Recruiting
Illinois
      nTouch Research, Peoria,  Illinois,  61602,  United States; Recruiting
      Carle Clinic Associates, Urbana,  Illinois,  61801,  United States; Recruiting
Iowa
      Gastrointestinal Clinic of Quad Cities, Davenport,  Iowa,  52807,  United States; Recruiting
Kentucky
      University of KY Medical Center, Lexington,  Kentucky,  40536,  United States; Recruiting
Louisiana
      Drug Research Services, Inc., Metairie,  Louisiana,  70006,  United States; Recruiting
Maryland
      Digestive Disorders Associates, Annapolis,  Maryland,  21404,  United States; Recruiting
      Vijay Naraygen, Baltimore,  Maryland,  21229,  United States; Recruiting
Massachusetts
      Coastal Research Associates, Braintree,  Massachusetts,  02184,  United States; Recruiting
Michigan
      Clinical Research Institute of Michigan, LLC, Chesterfield,  Michigan,  48047,  United States; Recruiting
Minnesota
      Minnesota Gastroenterology, Minneapolis,  Minnesota,  55404,  United States; Recruiting
Mississippi
      Digestive Health Specialists, PA, Tupelo,  Mississippi,  38801,  United States; Recruiting
Missouri
      Center for Digestive and Liver Diseases, Mexico,  Missouri,  65265,  United States; Recruiting
Montana
      Western Montana Clinic, PC, Missoula,  Montana,  59802,  United States; Recruiting
Nebraska
      Heartland Clinical Research, Inc., Omaha,  Nebraska,  68134,  United States; Recruiting
New Jersey
      Atlantic Gastroenterology Associates, PA, Egg Harbor Township,  New Jersey,  08234,  United States; Recruiting
New York
      Long Island Clinical Research Associates, Great Neck,  New York,  11021,  United States; Recruiting
      Asher Kornbluth MD, PC, New York,  New York,  10128,  United States; Recruiting
      Upstate Gastroenterology Associates, Troy,  New York,  12180,  United States; Recruiting
      Research Associates of New York, New York,  New York,  10021,  United States; Recruiting
      Simon Lichtiger, New York,  New York,  10128,  United States; Recruiting
North Carolina
      Charlotte Gastroenterology & Hepatology, Charlotte,  North Carolina,  28207,  United States; Recruiting
      Asheville Gastroenterology Associates, Asheville,  North Carolina,  28801,  United States; Recruiting
      Boice-Willis Clinic, Rocky Mount,  North Carolina,  27804,  United States; Recruiting
      Hanover Medical Specialists, PA, Wilmington,  North Carolina,  28401,  United States; Recruiting
      Carolina Research Center, Greenville,  North Carolina,  27834,  United States; Recruiting
      Wake Research Associates, LLC, Raleigh,  North Carolina,  27612,  United States; Recruiting
      East Carolina Gastroenterology, Jacksonville,  North Carolina,  28546,  United States; Recruiting
Ohio
      Wells Institute for Health Awareness, Kettering,  Ohio,  45429,  United States; Recruiting
      Consultants for Clinical Research, Cincinnati,  Ohio,  45219,  United States; Recruiting
      GI & Liver Consultants, Dayton,  Ohio,  45440,  United States; Recruiting
      GI & Liver Consultants, Dayton,  Ohio,  45440,  United States; Recruiting
Oklahoma
      Healthcare Research Consultants, Tulsa,  Oklahoma,  74135,  United States; Recruiting
      Oklahoma Foundation for Digestive Research, Oklahoma City,  Oklahoma,  73104,  United States; Recruiting
      Sooner Clinical Research, Oklahoma City,  Oklahoma,  73112,  United States; Recruiting
Oregon
      Portland Digestive Diseases Center, Portland,  Oregon,  97225,  United States; Recruiting
      The Oregon Clinic, Portland,  Oregon,  97220,  United States; Recruiting
Pennsylvania
      Americas Doctor (Susan Barred), Pittsburg,  Pennsylvania,  15224,  United States; Recruiting
      Altoona Center for Clinical Research, Duncansville,  Pennsylvania,  16635,  United States; Recruiting
South Carolina
      Columbia Gastroenterology Associates, Columbia,  South Carolina,  29203,  United States; Recruiting
Tennessee
      Gastroenterology Associates, Kingsport,  Tennessee,  37660,  United States; Recruiting
      Nashville Medical Research Institute, Nashville,  Tennessee,  37205,  United States; Recruiting
      Americas Doctor (Susan Barred), Nashville,  Tennessee,  37203,  United States; Recruiting
      Regional Research Institute, Jackson,  Tennessee,  38305,  United States; Recruiting
Texas
      Gastroenterology Clinic of San Antonio, San Antonio,  Texas,  78229,  United States; Recruiting
      System Endocrinology & Research Center, Houston,  Texas,  77024,  United States; Recruiting
      University of Texas Medical Branch, Galveston,  Texas,  77555,  United States; Recruiting
      George Willeford, Austin,  Texas,  78745,  United States; Recruiting
Utah
      Advanced Research Institute, Ogden,  Utah,  84405,  United States; Recruiting
      Salt Lake City Endoscopy, Salt Lake City,  Utah,  84122,  United States; Recruiting
Vermont
      Flecher Allen Health Care, South Burlington,  Vermont,  05403,  United States; Recruiting
Virginia
      Charlottesville Medical Research, Charlottesville,  Virginia,  22911,  United States; Recruiting
      Internal Medicine Associates, Danville,  Virginia,  24541,  United States; Recruiting
      McGuire DVAMC, Richmond,  Virginia,  23149,  United States; Recruiting
Washington
      Eastside Gastroenterology PS, Kirkland,  Washington,  98034,  United States; Recruiting
Wisconsin
      Discovery Research International, LLC, Milwaukee,  Wisconsin,  53215,  United States; Recruiting

Study ID Numbers:  197-02-220
Record last reviewed:  March 2005
Last Updated:  March 8, 2005
Record first received:  September 22, 2004
ClinicalTrials.gov Identifier:  NCT00092508
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08