FACTS II: A Study to Test the Safety and Effectiveness of a New Medication on the Treatment of Active Ulcerative Colitis

Completed · Phase 3

Conditions studied: Ulcerative Colitis

In brief

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.

Key facts

Study ID

NCT00064454

Run by

Otsuka Pharmaceutical Development & Commercialization, Inc.

People needed

375

Starts

2003-05-01

Expected to finish

2006-07-01

Last updated by the study team

2012-05-10

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Redpoint Research — Phoenix, Arizona, United States
• Desert Sun Gastroenterology — Tucson, Arizona, United States
• Central California Medical Research — Fresno, California, United States
• Rocky Mountain Clinical Research — Golden, Colorado, United States
• Gastroenterology Associated of Fairfield County — Bridgeport, Connecticut, United States
• Washington Fetterson, Washington Gastroenterology — Washington D.C., District of Columbia, United States
• Florida Medical Research Institute — Gainesville, Florida, United States
• Mark Lamet — Hollywood, Florida, United States
• Borland-Groover Clinic — Jacksonville, Florida, United States
• Bruce Salzberg — Atlanta, Georgia, United States
• Drug Research Services — Metairie, Louisiana, United States
• Metropolitan Gastroenterology Group — Chevy Chase, Maryland, United States
• Highland Medical Center — Braintree, Massachusetts, United States
• Minnesota Gastroenterology — Plymouth, Minnesota, United States
• Gastrointestial Associates, PA — Jackson, Mississippi, United States
• Affiliates in Gastroeneterology — Florham Park, New Jersey, United States
• Long Island Clinical Research Associates, LLP — Great Neck, New York, United States
• Asheville Gastroenterology Associates — Asheville, North Carolina, United States
• Charlotte Gastroenterology and Hepatology — Charlotte, North Carolina, United States
• Carolina Research Center — Greenville, North Carolina, United States
• Boice-Willis Clinic — Rocky Mount, North Carolina, United States
• West Hills Gastroenterology Associates — Portland, Oregon, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Gastrointestinal Associates — Knoxville, Tennessee, United States
• Nashville Medical Research Institute — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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