Thalidomide in Pediatric Inflammatory Bowel Diseases.

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.

Conditions

• Inflammatory Bowel Diseases
• Crohn's Disease
• Ulcerative Colitis

Interventions

DRUG

Thalidomide

Thalidomide 1.5-2.5 mg/kg/die once a day, at evening.

DRUG

placebo

placebo capsules

Sponsors & Collaborators

• Ospedale Meyer

  collaborator OTHER

• Pediatric Gastroenterology Unit, IRCCS Gaslini, Genoa.

  collaborator UNKNOWN

• Vittore Buzzi Children's Hospital

  collaborator OTHER

• University of Pisa

  collaborator OTHER

• University of Messina

  collaborator OTHER

• Università degli Studi di Brescia

  collaborator OTHER

• University of Trieste

  collaborator OTHER

• IRCCS Burlo Garofolo

  lead OTHER

Principal Investigators

• Alessandro Ventura, MD · IRCCS Burlo Garofolo

• Marzia Lazzerini, MD · IRCCS Burlo Garofolo

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

2 Years

Max Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-08-31

Primary Completion

2011-09-30

Completion

2012-06-30

Countries

• Italy

Study Locations