Thalidomide in Pediatric Inflammatory Bowel Diseases.
Status:
Completed
Trial end date:
2012-06-01
Target enrollment:
Participant gender:
Summary
Several open-label studies reported thalidomide efficacy in inducing clinical remission and
steroid tapering in refractory Inflammatory Bowel diseases (IBD), both in adults and in
children.
This is a randomized placebo controlled (RCT) double blind study, to evaluate the efficacy of
thalidomide in inducing clinical remission at 8 weeks in refractory IBD patients aged 2-20
years.
The primary hypotheses of the study is that thalidomide would be more effective than placebo
in inducing clinical remission.
The RCT phase is followed by a open-label phase, to further evaluate efficacy and safety of
thalidomide in thalidomide responders, with a total follow up of one year.
Phase:
Phase 3
Details
Lead Sponsor:
IRCCS Burlo Garofolo
Collaborators:
Ospedale Meyer Pediatric Gastroenterology Unit, IRCCS Gaslini, Genoa. Università degli Studi di Brescia University of Messina University of Pisa University of Trieste Vittore Buzzi Children's Hospital