CNI-1493 for Treatment of Moderate to Severe Crohn's Disease
NCT ID: NCT00038766
Last Updated: 2012-08-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
33 participants
INTERVENTIONAL
2002-06-30
2003-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Semapimod 60 mg
Semapimod 60 mg IV x 5 days
semapimod
semapipmod 60 mg IV x 5 days
Semapimod IV 30 mg
Semapimod IV 30 mg x 5 days
semapimod
IV 30 mg x 5 days
Placebo
Placebo IV x 3 or 5 days
placebo
placebo IV
Interventions
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semapimod
semapipmod 60 mg IV x 5 days
semapimod
IV 30 mg x 5 days
placebo
placebo IV
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Crohn's disease of at least 3 months duration, with colitis, ileitis, or ileocolitis, confirmed by radiography and/or endoscopy
* Patients receiving medications for CD must be on stable doses entering the study
* Any CD medication which has been discontinued must have been discontinued at least 4 weeks prior to screening, with the exception of infliximab, which must have been discontinued at least 8 weeks prior to screening
Exclusion Criteria
* Current evidence of bowel obstruction or history within the preceding six months as confirmed by radiography, endoscopy, or surgery
* Patients with stool examination positive for enteric pathogens, pathogenic ova or parasites, or Clostridium difficile toxin
* Treatment with any other experimental therapeutics within the last 4 weeks before enrollment
18 Years
ALL
No
Sponsors
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Ferring Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Daan Hommes, M
Role: PRINCIPAL_INVESTIGATOR
Academic Medical Center, Netherlands
Locations
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Institute of Healthcare Assessment
San Diego, California, United States
University of Florida
Gainesville, Florida, United States
Atlanta Gastroenterology Associates
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
Washington University School of Medicine
St Louis, Missouri, United States
Long Island Clinical Research Associates
Great Neck, New York, United States
Mount Sinai School of Medicine
New York, New York, United States
Charlotte Gastroenterology and Hepatology, PLLC
Charlotte, North Carolina, United States
Wake Research Associates
Raleigh, North Carolina, United States
Oklahoma Foundation for Digestive Research
Oklahoma City, Oklahoma, United States
Regional Gastroenterology Associates of Lancaster, Ltd.
Lancaster, Pennsylvania, United States
Digestive and Liver Disease Specialists
Norfolk, Virginia, United States
Countries
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References
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Hommes D, van den Blink B, Plasse T, Bartelsman J, Xu C, Macpherson B, Tytgat G, Peppelenbosch M, Van Deventer S. Inhibition of stress-activated MAP kinases induces clinical improvement in moderate to severe Crohn's disease. Gastroenterology. 2002 Jan;122(1):7-14. doi: 10.1053/gast.2002.30770.
Other Identifiers
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CNI-1493 CD-02
Identifier Type: -
Identifier Source: org_study_id