FACTS I: A Study to Test the Safety and Effectiveness of a New Medication on the Treatment of Active Ulcerative Colitis
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
1 other identifier
interventional
375
1 country
23
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started May 2003
Typical duration for phase_3
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2003
CompletedFirst Submitted
Initial submission to the registry
July 8, 2003
CompletedFirst Posted
Study publicly available on registry
July 10, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2006
CompletedMay 10, 2012
May 1, 2012
3 years
July 8, 2003
May 9, 2012
Conditions
Keywords
Interventions
Eligibility Criteria
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
- 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.
- Please see study Web site for additional information.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
Ascent Clinical Research
Scottsdale, Arizona, 85258, United States
West Gastroenterology Medical Group
Los Angeles, California, 90045, United States
Lovelace Scientific Resources
Santa Ana, California, 92704, United States
Western States Clinical Research, Inc.
Wheat Ridge, Colorado, 80033, United States
Lovelace Scientific Resources Florida
Miami, Florida, 33156, United States
Miami Research Associates
Miami, Florida, 33173, United States
Venture Research Institute LLC
North Miami Beach, Florida, 33162, United States
Gastroenterology Consultants, P.A.
Ormond Beach, Florida, 32174, United States
Gastroenterology Associates, LLC
Baton Rouge, Louisiana, 70809, United States
Digestive Disorders Associates
Annapolis, Maryland, 21401, United States
Digestive Disease Associates
Baltimore, Maryland, 21229, United States
Upstate Gastroenterology Associates
Troy, New York, 12180, United States
Bethany Medical Center
High Point, North Carolina, 27262, United States
Hanover Medical Specialists, P.A.
Wilmington, North Carolina, 28401, United States
Akron Gastroenterology Associates, Inc.
Akron, Ohio, United States
Consultants for Clinical Research
Cincinnati, Ohio, 45219, United States
Gastrointestinal and Liver Diseases Consultants
Dayton, Ohio, 45440, United States
Sooner Clinical Reserach
Oklahoma City, Oklahoma, 73112, United States
Columbia Gastroenterology Associates
Columbia, South Carolina, 29203, United States
Memphis Gastroenterology Group, PC
Memphis, Tennessee, 38120, United States
Digestive Associates of Houston
Houston, Texas, 77030, United States
Houston Digestive Diseases Clinic
Houston, Texas, 77090, United States
Digestive and Liver Disease Specialists
Norfolk, Virginia, 23502, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 8, 2003
First Posted
July 10, 2003
Study Start
May 1, 2003
Primary Completion
May 1, 2006
Study Completion
May 1, 2006
Last Updated
May 10, 2012
Record last verified: 2012-05