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

Ulcerative Colitis Clinical Trial

Official title:

FACTS II: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-arm Study of the Efficacy and Safety of OPC-6535 Tablets in the Treatment of Subjects With Active Ulcerative Colitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00064454
• Other study ID #: 197-02-218
• Status: Completed
• Phase: Phase 3
• First received: July 8, 2003
• Last updated: May 9, 2012
• Start date: May 2003
• Est. completion date: July 2006

Study information

• Verified date: May 2012
• Source: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 375
• Est. completion date: July 2006
• Est. primary completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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-a 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• OPC-6535 Tablets (drug)

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Development & Commercialization, Inc.

Country where clinical trial is conducted

United States,