CNI-1493 for Treatment of Moderate to Severe Crohn's Disease (CD02)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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: semapimod Drug: placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-Blind, Placebo-controlled Study of CNI-1493 for Treatment of Moderate to Severe Crohn's Disease |
- Change in CDAI [ Time Frame: Day 29 ] [ Designated as safety issue: No ]
- Change in IBDQ [ Time Frame: Day 29 ] [ Designated as safety issue: No ]
| Enrollment: | 33 |
| Study Start Date: | June 2002 |
| Study Completion Date: | June 2003 |
| Primary Completion Date: | June 2003 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Semapimod 60 mg
Semapimod 60 mg IV x 5 days
|
Drug: semapimod
semapipmod 60 mg IV x 5 days
Other Names:
|
|
Experimental: Semapimod IV 30 mg
Semapimod IV 30 mg x 5 days
|
Drug: semapimod
IV 30 mg x 5 days
Other Names:
|
|
Placebo Comparator: Placebo
Placebo IV x 3 or 5 days
|
Drug: placebo
placebo IV
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| 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 | |
| Charlotte Gastroenterology and Hepatology, PLLC | |
| Charlotte, North Carolina, United States, 28207 | |
| Wake Research Associates | |
| Raleigh, North Carolina, United States, 27612 | |
| 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 | |
| Principal Investigator: | Daan Hommes, M | Academic Medical Center, Netherlands |
More Information
Publications:
| Responsible Party: | Ferring Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00038766 History of Changes |
| Other Study ID Numbers: | CNI-1493 CD-02 |
| Study First Received: | June 5, 2002 |
| Last Updated: | August 22, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Ferring Pharmaceuticals:
|
Inflammatory Bowel Disease |
Additional relevant MeSH terms:
|
Crohn Disease Inflammatory Bowel Diseases Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases CNI 1493 Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics |
Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Immunosuppressive Agents Immunologic Factors Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 16, 2013