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NCT00252369 Clinical Trial

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

Crohn's Disease Clinical Trial

Official title:
Instillation of Fibrin Glue After Induction of Local Conditions Using Infliximab, in the Treatment of Perianal Crohn's Disease.

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00252369
Other study ID # SHEBA-05-3762-OZ-CTIL
Secondary ID
Status Terminated
Phase N/A
First received November 10, 2005
Last updated April 23, 2009

Study information
Verified date April 2009
Source Sheba Medical Center
Contact n/a
Is FDA regulated No
Health authority Israel: Israeli Health Ministry Pharmaceutical Administration
Study type Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Terminated
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria:

- Perianal fistula of Crohn's dis

Exclusion Criteria:

- More then 2 fistulae perianal sepsis known contraindication to infliximab or glue

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Infliximab

Procedure:
• Instillation of fibrin glue

Locations
Country Name City State
Israel Meir Medical Center Kfar Saba
Israel Tel Aviv Medical Center Tel Aviv
Israel Sheba Medical Center Tel Hashomer
Israel Assaf Harofe Medical Center Zrifin

Sponsors (1)
Lead Sponsor Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Fistula healing
Secondary Quality of life
Secondary Complications
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