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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00038766
Other study ID # CNI-1493 CD-02
Secondary ID
Status Terminated
Phase Phase 2
First received June 5, 2002
Last updated August 22, 2012
Start date June 2002
Est. completion date June 2003

Study information

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

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
semapimod
semapipmod 60 mg IV x 5 days
semapimod
IV 30 mg x 5 days
placebo
placebo IV

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Ferring Pharmaceuticals

Country where clinical trial is conducted

United States, 

References & Publications (1)

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

Outcome

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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