At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 77 enrolled
Drug / intervention
Fibrin glue injection in fistulaprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Fibrin Glue for Perianal Fistulas in Crohn's Disease: a Randomized Controlled Trial
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives·interventional·Posted Jul 28, 2008·Updated Sep 5, 2011
In Brief
A Phase 3 clinical trial evaluating Fibrin glue injection in fistula for Crohn's Disease. Completed, enrolled 77 participants across 14 sites in 2 countries.
Detailed Summary
This multicenter, randomized, controlled trial was conducted by the Groupe d'Etude Thérapeutique des Affections Inflammatoires du tube Digestif (GETAID) to evaluate the efficacy and safety of the injection of fibrin glue in perianal fistulas tracts of patients with CD. The institutional Independent Ethics Committee of Marseille, France and of Liège, Belgium approved the protocol for each participating centers. Recruitment took place at 12 sites (11 in France and 1 in Belgium)
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCrohn's Disease
CountriesBelgium, France
CollaboratorsNycomed, Société Nationale Française de Gastroentérologie
Timeline
Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartNov 2003
Primary CompletionJun 2006
Study CompletionAug 2006
First PostedJul 2008
TodayJul 2026
First PostedJul 28, 2008
Enrollment StartNov 1, 2003
Primary CompletionJun 1, 2006
Study CompletionAug 1, 2006
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 17.9 years ago
Interventions
Fibrin glue injection in fistulaprocedure