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Sponsored by: |
Cytokine PharmaSciences |
---|---|
Information provided by: | Cytokine PharmaSciences |
ClinicalTrials.gov Identifier: | NCT00038766 |
The purpose of this study is to determine whether CNI-1493 is safe and effective in the treatment of moderate to severe Crohn’s Disease.
Condition | Intervention | Phase |
---|---|---|
Crohn Disease |
Drug: CNI-1493 |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled Study of CNI-1493 for Treatment of Moderate to Severe Crohn’s Disease |
Estimated Enrollment: | 180 |
Study Start Date: | June 2002 |
Estimated Study Completion Date: | June 2003 |
Crohn’s disease (CD) is a chronic inflammatory disease involving the upper and lower gastrointestinal tract and characterized by abdominal pain, weight loss, gastrointestinal bleeding and formation of fistulas between loops of bowel and from the bowel to the skin or other organs. Current therapy for active Crohn’s disease consists of symptomatic treatment, nutritional therapy, salicylates and immunosuppressants or surgical management.
Tumor necrosis factor a (TNF-a) plays a central role in the initiation and amplification of the granulomatous inflammatory reaction seen in CD (van Deventer, 1997). Increased TNF-a is present in gut mucosa as well as in stool of patients with active CD (Braegger et al, 1992). CNI-1493 is a synthetic guanylhydrazone compound that is an inhibitor of TNF-a synthesis. A monoclonal antibody to TNF, infliximab, is now approved for treatment of CD, but not all patients respond and many who do respond eventually become refractory to this treatment as well.
CNI-1493 is a synthetic compound which blocks the production of several inflammatory cytokines, including TNF. Because it blocks production of multiple inflammatory mediators, it may be more active than products targeted to a specific cytokine. In addition, as it is not a biologic, it should not cause hypersensitivity reactions or induce formation of antibodies.
The purpose of this trial is to determine if CNI-1493 is safe and effective in treating patients with moderate to severe Crohn’s Disease in a placebo controlled setting.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
United States, California | |
Institute of Healthcare Assessment | |
San Diego, California, United States, 92120 | |
United States, Florida | |
University of Florida | |
Gainesville, Florida, United States | |
United States, Georgia | |
Atlanta Gastroenterology Associates | |
Atlanta, Georgia, United States, 30342 | |
United States, Illinois | |
Northwestern University | |
Chicago, Illinois, United States | |
University of Chicago | |
Chicago, Illinois, United States | |
United States, Missouri | |
Washington University School of Medicine | |
St. Louis, Missouri, United States | |
United States, New York | |
Long Island Clinical Research Associates | |
Great Neck, New York, United States, 11021 | |
Mount Sinai School of Medicine | |
New York, New York, United States | |
United States, North Carolina | |
Wake Research Associates | |
Raleigh, North Carolina, United States, 27612 | |
Charlotte Gastroenterology and Hepatology, PLLC | |
Charlotte, North Carolina, United States, 28207 | |
United States, Oklahoma | |
Oklahoma Foundation for Digestive Research | |
Oklahoma City, Oklahoma, United States | |
United States, Pennsylvania | |
Regional Gastroenterology Associates of Lancaster, Ltd. | |
Lancaster, Pennsylvania, United States, 17604 | |
United States, Virginia | |
Digestive and Liver Disease Specialists | |
Norfolk, Virginia, United States, 23502 |
Study ID Numbers: | CNI-1493 CD-02 |
Study First Received: | June 5, 2002 |
Last Updated: | May 2, 2006 |
ClinicalTrials.gov Identifier: | NCT00038766 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Inflammatory Bowel Disease |
Anti-Inflammatory Agents Crohn's Disease Immunologic Factors Ileitis Gastrointestinal Diseases Enteritis Inflammatory Bowel Diseases Intestinal Diseases Immunosuppressive Agents Ileal Diseases |
Digestive System Diseases Analgesics, Non-Narcotic Crohn Disease Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents Gastroenteritis CNI 1493 |
Anti-Inflammatory Agents Immunologic Factors Ileitis Gastrointestinal Diseases Enteritis Physiological Effects of Drugs Inflammatory Bowel Diseases Intestinal Diseases Immunosuppressive Agents Ileal Diseases Pharmacologic Actions Digestive System Diseases |
Sensory System Agents Analgesics, Non-Narcotic Therapeutic Uses Crohn Disease Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents Gastroenteritis Central Nervous System Agents CNI 1493 |