CNI-1493 for Treatment of Moderate to Severe Crohn's Disease

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Crohn Disease

In brief

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.

Key facts

Study ID

NCT00038766

Run by

Ferring Pharmaceuticals

People needed

33

Starts

2002-06-01

Expected to finish

2003-06-01

Last updated by the study team

2012-08-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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