Clinical trial NCT00064441: FACTS I: A Study to Test the Safety and Effectiveness of a New Medication on the Treatment of Active Ulcerative Colitis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ulcerative Colitis
Keywords: Ulcerative Colitis
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
First posted: 2003-07-10
Enrollment: 375
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Ascent Clinical Research
state: Arizona
city: Los Angeles
country: United States
facility: West Gastroenterology Medical Group
state: California
city: Santa Ana
country: United States
facility: Lovelace Scientific Resources
state: California
city: Wheat Ridge
country: United States
facility: Western States Clinical Research, Inc.
state: Colorado
city: Miami
country: United States
facility: Lovelace Scientific Resources Florida
state: Florida
city: Miami
country: United States
facility: Miami Research Associates
state: Florida
city: North Miami Beach
country: United States
facility: Venture Research Institute LLC
state: Florida
city: Ormond Beach
country: United States
facility: Gastroenterology Consultants, P.A.
state: Florida
city: Baton Rouge
country: United States
facility: Gastroenterology Associates, LLC
state: Louisiana
city: Annapolis
country: United States
facility: Digestive Disorders Associates
state: Maryland
city: Baltimore
country: United States
facility: Digestive Disease Associates
state: Maryland
city: Troy
country: United States
facility: Upstate Gastroenterology Associates
state: New York
city: High Point
country: United States
facility: Bethany Medical Center
state: North Carolina
city: Wilmington
country: United States
facility: Hanover Medical Specialists, P.A.
state: North Carolina
city: Akron
country: United States
facility: Akron Gastroenterology Associates, Inc.
state: Ohio
city: Cincinnati
country: United States
facility: Consultants for Clinical Research
state: Ohio
city: Dayton
country: United States
facility: Gastrointestinal and Liver Diseases Consultants
state: Ohio
city: Oklahoma City
country: United States
facility: Sooner Clinical Reserach
state: Oklahoma
city: Columbia
country: United States
facility: Columbia Gastroenterology Associates
state: South Carolina
city: Memphis
country: United States
facility: Memphis Gastroenterology Group, PC
state: Tennessee
city: Houston
country: United States
facility: Digestive Associates of Houston
state: Texas
city: Houston
country: United States
facility: Houston Digestive Diseases Clinic
state: Texas
city: Norfolk
country: United States
facility: Digestive and Liver Disease Specialists
state: Virginia
Study officials:
References: