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Treatment of Perianal Crohn's Disease, Combining Medical and Surgical Treatment.

This study has been terminated.
(Low accrual rate)
Sponsor:
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00252369
First received: November 10, 2005
Last updated: April 23, 2009
Last verified: April 2009

November 10, 2005
April 23, 2009
Not Provided
Not Provided
Fistula healing
Same as current
Complete list of historical versions of study NCT00252369 on ClinicalTrials.gov Archive Site
  • Quality of life
  • Complications
Same as current
Not Provided
Not Provided
 
Treatment of Perianal Crohn's Disease, Combining Medical and Surgical Treatment.
Instillation of Fibrin Glue After Induction of Local Conditions Using Infliximab, in the Treatment of Perianal Crohn's Disease.

This study is aimed to assess the hypothesis that instillation of fibrin glue with the induction of local conditions using Infliximab, may be useful in the treatment of perianal Crohn's disease.

Patients with perianal fistulae of Crohn's disease will be prospectively enrolled and receive 3 doses of Infliximab. If reduction of fistula associated discharge of at least 50% will be recorded, commercially available fibrin glue will be instilled into the fistula tract using standard surgical techniques. The patients will be followed for 6 months for fistula healing and complications.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Crohn's Disease
  • Drug: Infliximab
  • Procedure: Instillation of fibrin glue
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
Not Provided
Not Provided
Not Provided

Inclusion Criteria:

  • Perianal fistula of Crohn's dis

Exclusion Criteria:

  • More then 2 fistulae perianal sepsis known contraindication to infliximab or glue
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00252369
SHEBA-05-3762-OZ-CTIL
No
Not Provided
Sheba Medical Center
Not Provided
Principal Investigator: Oded Zmora, MD Sheba Medical Center
Sheba Medical Center
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP