The purpose of this study is to evaluate the safety and efficacy of the drug OPC-6535 compared to a placebo in patients with active Ulcerative Colitis.

Depending on their response, participants will be offered the investigational medication for up to one year after the study’s completion at select sites.

Condition	Treatment or Intervention	Phase
Ulcerative Colitis	Drug: OPC-6535 Tablets (drug)	Phase III

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

Criteria

Inclusion Criteria:

• Male or female subjects, 18-80 years of age, inclusive, who provide written informed consent prior to any study-related procedures and who are, in the opinion of the Investigator, likely to comply with all the requirements of the study
• Subjects with established diagnosis of active ulcerative colitis, who have relapsed within 12 weeks before screening. All subjects must have had the diagnosis of ulcerative colitis established by colonoscopy* prior to entering the study. (Newly diagnosed patients are also eligible.) * Colonoscopy may be substituted for flexible sigmoidoscopy during Screening if this inclusion criterion is not met.
• Colonic involvement with ulcerative colitis beyond 15 cm of the anal verge.
• Subjects with active disease, as defined by a DAI score between 7 and 11, inclusive, at the Screening/Baseline Visit.
• A score of ≥2 for rectal bleeding and a score ≥ 0 on flexible sigmoidoscopy at the Screening/Baseline Visit, based on DAI criteria.
• Subjects who have been on a stable dose of 5-ASA for at least 14 days prior to the Screening/Baseline Visit OR subjects who have not been receiving any 5-ASA for at least 14 days.
• Subjects who are surgically sterilized or who are prepared to and agree to practice a double-barrier form of birth control from the Screening/Baseline Visit through 30 (females) and 90 (males) days, 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 severe disease, defined as DAI of 12 at the Screening/Baseline Visit, and/or subjects whom the Investigator deems likely to require immunosuppressant therapy including corticosteroids and/or hospitalization during the period of study.
• Subjects who have any other clinically significant disease(s) which, in the opinion of the Investigator, could compromise the subject’s involvement in the study and/or interfere with the absorption of the study drug or the overall interpretation of the data.
• 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 oral corticosteroids (including oral budesonide) within 30 days, or topical intrarectal agents (corticosteroids or 5-ASA enemas, suppositories, foams) within 7 days of Screening/Baseline. (Topical dermatological corticosteroids are not excluded).
• Subjects who have used immunosuppressants including, but not limited to: azathioprine, 6-mercaptopurine, methotrexate, within 28 days or IL-10, IL-11, FK-506 [tacrolimus], mycophenolate, cyclosporine, anti-TNF-α or monoclonal antibody medications within 60 days of Screening/Baseline.
• Subjects who have a history of active malignancies within 5 years (surgically-treated basal cell, squamous cell, non-melanoma or in situ cervical carcinomas permissible), an intra-abdominal abscess, a toxic megacolon, or a clinical instability resulting from any other cause.
• Subjects with a known or suspected history of sclerosing cholangitis.
• Subjects with a known or suspected history of clinically relevant cardiac disease.
• Subjects with a positive stool culture for any enteric pathogens, pathogenic ova or parasites, or a positive EIA that is subsequently confirmed by a positive cytotoxin assay for C. difficile toxin. (Results for any enteric pathogens, pathogenic ova or parasites, but not C. difficile toxin, may be pending at the time of randomization and study drug initiation.)
• Subjects with a partial bowel obstruction, as documented by proximal small bowel dilation at Screening/Baseline.

Additional exclusion criteria apply.

Please see study Web site for additional information.

Matthews Group      1-866-707-8839    info@colitistrial.com

Arizona
      Ascent Clinical Research, Scottsdale,  Arizona,  85258,  United States; Recruiting
California
      West Gastroenterology Medical Group, Los Angeles,  California,  90045,  United States; Recruiting
      Lovelace Scientific Resources, Santa Ana,  California,  92704,  United States; Recruiting
Colorado
      Western States Clinical Research, Inc., Wheat Ridge,  Colorado,  80033,  United States; Recruiting
Florida
      Venture Research Institute LLC, North Miami Beach,  Florida,  33162,  United States; Recruiting
      The Ford Research Institute, Pensacola,  Florida,  32514,  United States; Recruiting
      Miami Research Associates, Miami,  Florida,  33173,  United States; Recruiting
      Gastroenterology Consultants, P.A., Ormond Beach,  Florida,  32174,  United States; Recruiting
      Anchor Research Center, Naples,  Florida,  34107,  United States; Recruiting
      Lovelace Scientific Resources Florida, Miami,  Florida,  33156,  United States; Recruiting
Illinois
      nTouch Research, Peoria,  Illinois,  61602,  United States; Recruiting
Maryland
      Digestive Disorders Associates, Annapolis,  Maryland,  21401,  United States; Recruiting
Montana
      Western Montana Clinic, P.C., Missoula,  Montana,  59802,  United States; Recruiting
Nevada
      Vishvinder Sharma, Las Vegas,  Nevada,  89104,  United States; Recruiting
New York
      Upstate Gastroenterology Associates, Troy,  New York,  12180,  United States; Recruiting
      Research Associates of New York, New York,  New York,  10121,  United States; Recruiting
North Carolina
      Hanover Medical Specialists, P.A., Wilmington,  North Carolina,  28401,  United States; Recruiting
      East Carolina Gastroenterology, Jacksonville,  North Carolina,  28546,  United States; Recruiting
Ohio
      Akron Gastroenterology Associates, Inc., Akron,  Ohio,  United States; Recruiting
      Consultants for Clinical Research, Cincinnati,  Ohio,  45219,  United States; Recruiting
Oklahoma
      The Lynn Health Science Institute, Oklahoma City,  Oklahoma,  73112,  United States; Recruiting
Pennsylvania
      Keystone Digestive Disorders Consultants, Pittsburgh,  Pennsylvania,  15224,  United States; Recruiting
      Blair Gastroenterology Associates, Altoona,  Pennsylvania,  16602,  United States; Recruiting
South Carolina
      Columbia Gastroenterology Associates, Columbia,  South Carolina,  29203,  United States; Recruiting
Tennessee
      Southeastern Clinical Research, Chattanooga,  Tennessee,  37403,  United States; Recruiting
      Nashville Gastroenterology Consultants, P.C., Nashville,  Tennessee,  37203,  United States; Recruiting
      Regional Research Institute, Jackson,  Tennessee,  38305,  United States; Recruiting
      Memphis Gastroenterology Group, PC, Memphis,  Tennessee,  38120,  United States; Recruiting
Texas
      Digestive Disease Associates of Dallas, Dallas,  Texas,  75231,  United States; Recruiting
      Houston Digestive Diseases Clinic, Houston,  Texas,  77090,  United States; Recruiting
Virginia
      Digestive and Liver Disease Specialists, Norfolk,  Virginia,  23502,  United States; Recruiting
      Gastroenterology Associates of Tidewater, Chesapeake,  Virginia,  23320,  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:  197-02-217
Record last reviewed:  November 2004
Record first received:  July 8, 2003
ClinicalTrials.gov Identifier:  NCT00064441
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-11-10