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FACTS I: A Study to Test the Safety and Effectiveness of a New Medication on the Treatment of Active Ulcerative Colitis Clinical Trials References presented on Clinical Trials Search isn't meant to be a substitute for proven healthcare advice, trips or professional assistance using a genuine physician. We are not docs. Always confer with your physician about FACTS I: 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 devoted to listing clinical research studies in human subjects. FACTS I: A Study to Test the Safety and Effectiveness of a New Medication on the Treatment of Active Ulcerative Colitis Clinical research trials and FACTS I: A Study to Test the Safety and Effectiveness of a New Medication on the Treatment of Active Ulcerative Colitis healthcare trials happen in hundreds of localities throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the potency of new drugs. The propose of the studies / projects is to answer particular human health questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to detect cures for all sorts of conditions, such as FACTS I: A Study to Test the Safety and Effectiveness of a New Medication on the Treatment of Active Ulcerative Colitis. FACTS I: 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 volunteers to acquire healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a FACTS I: A Study to Test the Safety and Effectiveness of a New Medication on the Treatment of Active Ulcerative Colitis clinical trial. Subjects frequently obtain the most expert healthcare possible for their FACTS I: A Study to Test the Safety and Effectiveness of a New Medication on the Treatment of Active Ulcerative Colitis condition. Risks are a reality, nevertheless, and can include more or frequent doctor trips, medical risks (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with stern guidelines to protect clinical trials patients.
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Home > "F" Clinical Trials Conditions > FACTS I: A Study to Test the Safety and Effectiveness of a New Medication on the Treatment of Active Ulcerative Colitis  FACTS I: A Study to Test the Safety and Effectiveness of a New Medication on the Treatment of Active Ulcerative Colitis
FACTS I: 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:
Beacon Medical Research *Recruiting*
Indianapolis, Indiana, 46208
United States
Recruiting
Akron Gastroenterology Associates, Inc. *Recruiting*
Akron, Ohio,
United States
Recruiting
Gastroenterology Consultants, P.A. *Recruiting*
Ormond Beach, Florida, 32174
United States
Recruiting
Columbia Gastroenterology Associates *Recruiting*
Columbia, South Carolina, 29203
United States
Recruiting
Lovelace Scientific Resources *Recruiting*
Irvine, California, 92618
United States
Recruiting
Gastroenterology Associates *Recruiting*
Kingsport, Tennessee, 37660
United States
Recruiting
West Gastroenterology Medical Group *Recruiting*
Los Angeles, California, 90045
United States
Recruiting
Cleveland Clinic Foundation *Recruiting*
Cleveland, Ohio, 44195
United States
Recruiting
The Ford Research Institute *Recruiting*
Pensacola, Florida, 32514
United States
Recruiting
Guthrie Clinic *Recruiting*
Sayre, Pennsylvania, 18840
United States
Recruiting
Nashville Gastroenterology Consultants, P.C. *Recruiting*
Nashville, Tennessee, 37203
United States
Recruiting
The Lynn Health Science Institute *Recruiting*
Oklahoma City, Oklahoma, 73112
United States
Recruiting
Venture Research Institute LLC *Recruiting*
Miami, Florida, 33162
United States
Recruiting
Southeastern Clinical Research *Recruiting*
Chattanooga, Tennessee, 37403
United States
Recruiting
Consultants for Clinical Research *Recruiting*
Cincinnati, Ohio, 45219
United States
Recruiting
Keystone Digestive Disorders Consultants *Recruiting*
Pittsburgh, Pennsylvania, 15224
United States
Recruiting
Research Associates of New York *Recruiting*
New York City, New York, 10121
United States
Recruiting
Oklahoma Foundation for Digestive Research *Recruiting*
Oklahoma City, Oklahoma, 73104
United States
Recruiting
Western Montana Clinic, P.C. *Recruiting*
Missoula, Montana, 59802
United States
Recruiting
Western States Clinical Research, Inc. *Recruiting*
Arvada, Colorado, 80002
United States
Recruiting
Hanover Medical Specialists, P.A. *Recruiting*
Wilmington, North Carolina, 28401
United States
Recruiting
nTouch Research *Recruiting*
Peoria, Illinois, 61602
United States
Recruiting
Regional Research Institute *Recruiting*
Jackson, Tennessee, 38305
United States
Recruiting
Gastroenterology Group of South Jersey *Recruiting*
Vineland, New Jersey, 08360
United States
Recruiting
Miami Research Associates *Recruiting*
Miami, Florida, 33173
United States
Recruiting
Upstate Gastroenterology Associates *Recruiting*
Troy, New York, 12180
United States
Recruiting
Eastside Gastroenterology PS *Recruiting*
Kirkland, Washington, 98034
United States
Recruiting
William Stevens, MD *Recruiting*
Dallas, Texas, 75231
United States
Recruiting
Digestive and Liver Disease Specialists *Recruiting*
Norfolk, Virginia, 23502
United States
Recruiting
Allegheny Center for Digestive Health *Recruiting*
Pittsburgh, Pennsylvania, 15212
United States
Recruiting
SLU GI Studies Unit *Recruiting*
St. Louis, Missouri, 63104
United States
Recruiting
Discovery Research International, LLC *Recruiting*
Milwaukee, Wisconsin, 53215
United States
Recruiting
Additional Information:
Study ID Numbers: 197-02-217;
Study Start Date: May 2003
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00064441
Other Ulcerative Colitis Studies:
1. Left-Sided Ulcerative Colitis Study
2. A Randomized Trial of Rosiglitazone for Ulcerative Colitis
3. Quality of Life in Pediatric Inflammatory Bowel Disease
4. FACTS II: A Study to Test the Safety and Effectiveness of a New Medication on the Treatment of Active Ulcerative Colitis
5. Phase II Placebo-Controlled Study of 4-Aminosalicylic Acid for Ulcerative Colitis
Related Studies:
Other Ulcerative Colitis Clinical Trials
Other Washington Clinical Trials
Other Kirkland Clinical Trials
FACTS I: A Study to Test the Safety and Effectiveness of a New Medication on the Treatment of Active Ulcerative Colitis
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