Fibrin Glue for Perianal Fistulas in Crohn's Disease: a Randomized Controlled Trial

NCT00723047 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2011-09-05

No results posted yet for this study

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)

Conditions

Interventions

PROCEDURE

Fibrin glue injection in fistula

Sponsors & Collaborators

  • Nycomed

    collaborator INDUSTRY
  • Société Nationale Française de Gastroentérologie

    collaborator OTHER
  • Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-11-30
Primary Completion
2006-06-30
Completion
2006-08-31

Countries

  • Belgium
  • France

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00723047 on ClinicalTrials.gov