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FACTS II: A Study to Test the Safety and Effectiveness of a New Medication on the Treatment of Active Ulcerative Colitis Clinical Trials Information presented on Clinical Trials Search is not intended to be a substitute for qualified health advice, trips or treatment by using a genuine doctor. We aren't doctors. Always consult your mD on FACTS II: A Study to Test the Safety and Effectiveness of a New Medication on the Treatment of Active Ulcerative Colitis conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. FACTS II: A Study to Test the Safety and Effectiveness of a New Medication on the Treatment of Active Ulcerative Colitis Clinical research trials and FACTS II: A Study to Test the Safety and Effectiveness of a New Medication on the Treatment of Active Ulcerative Colitis health trials take place in a lot of of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / projects is to answer specific human medical questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, like FACTS II: A Study to Test the Safety and Effectiveness of a New Medication on the Treatment of Active Ulcerative Colitis. FACTS II: A Study to Test the Safety and Effectiveness of a New Medication on the Treatment of Active Ulcerative Colitis Clinical Trials and other clinical trials allow for volunteers to have health treatment alternatives before they are available to the general public. Many times the test subjects obtain treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a FACTS II: A Study to Test the Safety and Effectiveness of a New Medication on the Treatment of Active Ulcerative Colitis clinical trial. Subjects oftentimes recieve the most effective healthcare possible for their FACTS II: A Study to Test the Safety and Effectiveness of a New Medication on the Treatment of Active Ulcerative Colitis condition. Hazards are a reality, however, and could include additional or frequent doctor visits, healthcare dangers (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
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Home > "F" Clinical Trials Conditions > FACTS II: A Study to Test the Safety and Effectiveness of a New Medication on the Treatment of Active Ulcerative Colitis  FACTS II: A Study to Test the Safety and Effectiveness of a New Medication on the Treatment of Active Ulcerative Colitis
FACTS II: A Study to Test the Safety and Effectiveness of a New Medication on the Treatment of Active Ulcerative Colitis
For Condition: Ulcerative Colitis
Status: Recruiting
Sponsor(s): Otsuka Maryland Research Institute ,
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/80 Years
Genders: Both
Protocol Entry 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. Newly diagnosed patients are also eligible. - 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 steroids (including oral budesonide) within 30 days, or rectal steroids within 7 days of Screening/Baseline. - Subjects who have used immunosuppressants (including, but not limited to: azathioprine, 6-mercaptopurine, methotrexate, IL-10, IL-11, FK-506[tacrolimus], mycophenalate, cyclosporine, anti-TNF-α or a monoclonal antibody) within 60 days for Screening/Baseline. - Subjects who have a history of malignancies (surgically-treated basal cell, squamous cell, 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 assay for C. difficile toxin. (Results 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.
Total Enrollment: 375
Location and Contact Information:
George Washington University *Recruiting*
Washington D.C., District of Columbia, 20037
United States
Recruiting
University of Wisconsin Medical School *Recruiting*
Madison, Wisconsin, 53792
United States
Recruiting
Healthcare Research Consultants *Recruiting*
Tulsa, Oklahoma, 74135
United States
Recruiting
Fletcher Allen Health Care *Recruiting*
Burlington, Vermont,
United States
Recruiting
Carolina Research Center *Recruiting*
Greenville, North Carolina, 27834
United States
Recruiting
Minnesota Gastroenterology *Recruiting*
Plymouth, Minnesota, 55446
United States
Recruiting
Radiant Research *Recruiting*
Lake Worth, Florida, 33461
United States
Recruiting
Clinical Applications Laboratories, Inc. *Recruiting*
San Diego, California, 92103
United States
Recruiting
Medical Associates Research Group *Recruiting*
San Diego, California, 92123
United States
Recruiting
Wells Institute for Health Awareness *Recruiting*
Kettering, Ohio, 45429
United States
Recruiting
Borland-Groover Clinic *Recruiting*
Jacksonville, Florida, 32256
United States
Recruiting
Asheville Gastroenterology Associates *Recruiting*
Asheville, North Carolina, 28801
United States
Recruiting
Sharp Rees-Stealy Medical Group *Recruiting*
San Diego, California, 92123
United States
Recruiting
Charlotte Gastroenterology and Hepatology *Recruiting*
Charlotte, North Carolina, 28207
United States
Recruiting
Omni Healthcare, P.A. *Recruiting*
Melbourne, Florida, 32901
United States
Recruiting
The Oregon Clinic *Recruiting*
Portland, Oregon, 97220
United States
Recruiting
Medical University of South Carolina *Recruiting*
Charleston, South Carolina, 29425
United States
Recruiting
Center for Nutrition and Digestive Disorders *Recruiting*
Hanover, Pennsylvania, 17331
United States
Recruiting
Metropolitan Gastroenterology Group *Recruiting*
Chevy Chase, Maryland, 20815
United States
Recruiting
Long Island Clinical Research Associates, LLP *Recruiting*
Great Neck, New York, 11021
United States
Recruiting
University of Arkansas for Medical Science *Recruiting*
Little Rock, Arkansas, 72205
United States
Recruiting
West Hills Gastroenterology Associates *Recruiting*
Portland, Oregon, 97225
United States
Recruiting
Southern Illinois University School of Medicine- Division of Gastroenterology *Recruiting*
Springfield, Illinois, 62702
United States
Recruiting
Nashville Medical Research Institute *Recruiting*
Nashville, Tennessee, 37205
United States
Recruiting
Center for Digestive Diseases *Recruiting*
St. Petersburg, Florida, 33707
United States
Recruiting
Regional Gastroenterology Associates of Lancaster *Recruiting*
Lancaster, Pennsylvania, 17604
United States
Recruiting
Central California Medical Research *Recruiting*
Fresno, California, 93720
United States
Recruiting
Boice-Willis Clinic *Recruiting*
Rocky Mount, North Carolina, 27804
United States
Recruiting
University of Chicago Hospital *Recruiting*
Chicago, Illinois, 60637-1470
United States
Recruiting
Internal Medicine Associates *Recruiting*
Danville, Virginia, 24541
United States
Recruiting
Atlantic Gastro Associates, P.A. *Recruiting*
Egg Harbor, New Jersey, 08234
United States
Recruiting
Research Foundation of America *Recruiting*
Los Angeles, California, 90035
United States
Recruiting
Additional Information:
Study ID Numbers: 197-02-218;
Study Start Date: May 2003
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00064454
Other Ulcerative Colitis Studies:
1. Immune Regulation in Ulcerative Colitis or Crohn's Disease
2. Quality of Life in Pediatric Inflammatory Bowel Disease
3. FACTS II: A Study to Test the Safety and Effectiveness of a New Medication on the Treatment of Active Ulcerative Colitis
4. Left-Sided Ulcerative Colitis Study
5. A Randomized Trial of Rosiglitazone for Ulcerative Colitis
Related Studies:
Other Ulcerative Colitis Clinical Trials
Other California Clinical Trials
Other Fresno Clinical Trials
FACTS II: A Study to Test the Safety and Effectiveness of a New Medication on the Treatment of Active Ulcerative Colitis
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