Clinical trial NCT00064454: FACTS II: A Study to Test the Safety and Effectiveness of a New Medication on the Treatment of Active Ulcerative Colitis
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
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: Phoenix
country: United States
facility: Redpoint Research
state: Arizona
city: Tucson
country: United States
facility: Desert Sun Gastroenterology
state: Arizona
city: Fresno
country: United States
facility: Central California Medical Research
state: California
city: Golden
country: United States
facility: Rocky Mountain Clinical Research
state: Colorado
city: Bridgeport
country: United States
facility: Gastroenterology Associated of Fairfield County
state: Connecticut
city: Washington
country: United States
facility: Washington Fetterson, Washington Gastroenterology
state: District of Columbia
city: Gainesville
country: United States
facility: Florida Medical Research Institute
state: Florida
city: Hollywood
country: United States
facility: Mark Lamet
state: Florida
city: Jacksonville
country: United States
facility: Borland-Groover Clinic
state: Florida
city: Atlanta
country: United States
facility: Bruce Salzberg
state: Georgia
city: Metairie
country: United States
facility: Drug Research Services
state: Louisiana
city: Chevy Chase
country: United States
facility: Metropolitan Gastroenterology Group
state: Maryland
city: Braintree
country: United States
facility: Highland Medical Center
state: Massachusetts
city: Plymouth
country: United States
facility: Minnesota Gastroenterology
state: Minnesota
city: Jackson
country: United States
facility: Gastrointestial Associates, PA
state: Mississippi
city: Florham Park
country: United States
facility: Affiliates in Gastroeneterology
state: New Jersey
city: Great Neck
country: United States
facility: Long Island Clinical Research Associates, LLP
state: New York
city: Asheville
country: United States
facility: Asheville Gastroenterology Associates
state: North Carolina
city: Charlotte
country: United States
facility: Charlotte Gastroenterology and Hepatology
state: North Carolina
city: Greenville
country: United States
facility: Carolina Research Center
state: North Carolina
city: Rocky Mount
country: United States
facility: Boice-Willis Clinic
state: North Carolina
city: Portland
country: United States
facility: West Hills Gastroenterology Associates
state: Oregon
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Knoxville
country: United States
facility: Gastrointestinal Associates
state: Tennessee
city: Nashville
country: United States
facility: Nashville Medical Research Institute
state: Tennessee
city: Houston
country: United States
facility: System Endocrinology & Research Center
state: Texas
city: Danville
country: United States
facility: Internal Medicine Associates
state: Virginia
city: Madison
country: United States
facility: University of Wisconsin Medical School
state: Wisconsin
Study officials:
References: