Crohn Disease Clinical Trial
— CD02Official title:
A Randomized, Double-Blind, Placebo-controlled Study of CNI-1493 for Treatment of Moderate to Severe Crohn's Disease
Verified date | August 2012 |
Source | Ferring Pharmaceuticals |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 33 |
Est. completion date | June 2003 |
Est. primary completion date | June 2003 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria - Baseline Crohn's Disease Activity Index (CDAI) 250-400, inclusive - 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 - Patients with any ostomy or extensive bowel resection - 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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Atlanta Gastroenterology Associates | Atlanta | Georgia |
United States | Charlotte Gastroenterology and Hepatology, PLLC | Charlotte | North Carolina |
United States | Northwestern University | Chicago | Illinois |
United States | University of Chicago | Chicago | Illinois |
United States | University of Florida | Gainesville | Florida |
United States | Long Island Clinical Research Associates | Great Neck | New York |
United States | Regional Gastroenterology Associates of Lancaster, Ltd. | Lancaster | Pennsylvania |
United States | Mount Sinai School of Medicine | New York | New York |
United States | Digestive and Liver Disease Specialists | Norfolk | Virginia |
United States | Oklahoma Foundation for Digestive Research | Oklahoma City | Oklahoma |
United States | Wake Research Associates | Raleigh | North Carolina |
United States | Institute of Healthcare Assessment | San Diego | California |
United States | Washington University School of Medicine | St. Louis | Missouri |
Lead Sponsor | Collaborator |
---|---|
Ferring Pharmaceuticals |
United States,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in CDAI | Day 29 | No | |
Secondary | Change in IBDQ | Day 29 | No |
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