FACTS I: 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 I: 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: NCT00064441
• Other study ID #: 197-02-217
• Status: Completed
• Phase: Phase 3
• First received: July 8, 2003
• Last updated: May 9, 2012
• Start date: May 2003
• Est. completion date: May 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: May 2006
• Est. primary completion date: May 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	Akron Gastroenterology Associates, Inc.	Akron	Ohio
United States	Digestive Disorders Associates	Annapolis	Maryland
United States	Digestive Disease Associates	Baltimore	Maryland
United States	Gastroenterology Associates, LLC	Baton Rouge	Louisiana
United States	Consultants for Clinical Research	Cincinnati	Ohio
United States	Columbia Gastroenterology Associates	Columbia	South Carolina
United States	Gastrointestinal and Liver Diseases Consultants	Dayton	Ohio
United States	Bethany Medical Center	High Point	North Carolina
United States	Digestive Associates of Houston	Houston	Texas
United States	Houston Digestive Diseases Clinic	Houston	Texas
United States	West Gastroenterology Medical Group	Los Angeles	California
United States	Memphis Gastroenterology Group, PC	Memphis	Tennessee
United States	Lovelace Scientific Resources Florida	Miami	Florida
United States	Miami Research Associates	Miami	Florida
United States	Digestive and Liver Disease Specialists	Norfolk	Virginia
United States	Venture Research Institute LLC	North Miami Beach	Florida
United States	Sooner Clinical Reserach	Oklahoma City	Oklahoma
United States	Gastroenterology Consultants, P.A.	Ormond Beach	Florida
United States	Lovelace Scientific Resources	Santa Ana	California
United States	Ascent Clinical Research	Scottsdale	Arizona
United States	Upstate Gastroenterology Associates	Troy	New York
United States	Western States Clinical Research, Inc.	Wheat Ridge	Colorado
United States	Hanover Medical Specialists, P.A.	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Development & Commercialization, Inc.

Country where clinical trial is conducted

United States,