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Main
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Note: This record shows only 24 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00723047 |
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Date of registration:
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25/07/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Fibrin Glue for Perianal Fistulas in Crohn's Disease: a Randomized Controlled Trial
Fibrin glue |
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Scientific title:
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Fibrin Glue for Perianal Fistulas in Crohn's Disease: a Randomized Controlled Trial |
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Date of first enrolment:
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November 2003 |
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Target sample size:
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77 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00723047 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Belgium
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France
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- at least 18 years old
- CD confirmed by endoscopy and histology.
- CDAI should be 250 or less
- at least one perianal fistula (between anus or low rectum and perineum, vulva or
vagina) draining for more than 2 months duration
Exclusion Criteria:
- treatment with an anti-TNF agent or with ciclosporin or tacrolimus within the last 3
months
- presence of a perianal abscess (>1cm) assessed by magnetic resonance imaging (MRI) or
endo-anal ultrasonography performed within the last month,
- presence of anal or rectal stenosis,
- surgery during the previous month (except seton removal),
- previous fibrin glue injection,
- pregnancy.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Crohn's Disease
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Intervention(s)
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Procedure: Fibrin glue injection in fistula
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Primary Outcome(s)
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Clinical Remission
[Time Frame: 8 weeks after inclusion]
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Secondary Outcome(s)
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Occurrence of perianal abcess
[Time Frame: During whole study]
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Early Clinical Remission
[Time Frame: 4 weeks after Inclusion]
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Secondary ID(s)
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GETAID 2003-1
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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| Results available: |
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