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Thalidomide in Pediatric Inflammatory Bowel Diseases. (TALIBDP)

This study has been completed.
Ospedale Meyer
Pediatric Gastroenterology Unit, IRCCS Gaslini, Genoa.
Vittore Buzzi Children's Hospital
University of Pisa
University of Messina
Università degli Studi di Brescia
University of Trieste
Information provided by (Responsible Party):
Alessandro Ventura, IRCCS Burlo Garofolo Identifier:
First received: July 18, 2008
Last updated: October 25, 2012
Last verified: October 2012

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.

Condition Intervention Phase
Inflammatory Bowel Diseases Crohn's Disease Ulcerative Colitis Drug: Thalidomide Drug: placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Double-blind Vs. Placebo Multicentre Study on the Safety and Effectiveness of Thalidomide in the Treatment of Refractory Crohn's Disease and Ulcerative Colitis.

Resource links provided by NLM:

Further study details as provided by Alessandro Ventura, IRCCS Burlo Garofolo:

Primary Outcome Measures:
  • Clinical Remission [ Time Frame: 8°, 12°, 26, 52° weeks ]

Secondary Outcome Measures:
  • Clinical response [ Time Frame: 4°, 8° weeks ]
  • Steroid dose reduction [ Time Frame: 8°, 12°, 26, 52° weeks ]
  • Endoscopic remission [ Time Frame: 12°, 26, 52° weeks ]
  • Adverse effects [ Time Frame: 4°, 8°, 12°, 26, 52° weeks ]
  • Nutritinal indicators [ Time Frame: 8°, 52° ]
    Weight-on-age z-scores (WAZ) 8°, 52° Body Mass Index (BMI) z-scores 8°, 52° Height-on-age z-scores (HAZ) 52°

Enrollment: 84
Study Start Date: August 2008
Study Completion Date: June 2012
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Drug: Thalidomide
Thalidomide 1.5-2.5 mg/kg/die once a day, at evening.
Other Names:
  • Thalidomide PHARMION
  • Thalidomid CELGENE
Placebo Comparator: 2
Drug: placebo
placebo capsules

  Show Detailed Description


Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Children, adolescents and young adults aged 2 to 20 with chronic refractory moderate to severe inflammatory bowel disease, referred by the six pediatric gastroenterological centres participating in the study.

Definition of patient with refractory disease:

  • Patients with active disease despite steroid therapy (prednisone at a dose 2 mg/kg/die, maximum 60mg/day, or equivalent) for 8 weeks and/or an immunosuppressive of proven efficacy (azathioprine o 6-mercaptopurine for 4 months; methotrexate for 3 months; Infliximab at the dose of 5 mg/kg at week 0,2,6 weeks; cyclosporine at the dose of 2mg/kg/day for 4 weeks or 1 week at 1m/kg/day EV) or patients exhibiting intolerance to these drugs which prevent them from continuing treatment.

Exclusion Criteria:

  • Patients with ileostomy or colostomy.
  • Disease requiring immediate surgical intervention.
  • Severe ulcerative colitis or toxic megacolon.
  • Contraindications to using thalidomide (on-going pregnancy, neuropathy) .
  • Any of the following conditions: active infection, stool culture positive for enteric pathogens, tumors, HIV, transplanted organ, or non-controlled disease of the kidney, liver, endocrine system, heart, blood, nervous system or brain.
  • Patients being treated with other drugs as part of an experimental study.
  • Patients treated with infliximab in the previous eight weeks.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00720538

Department of Pediatrics, Ospedale Meyer.
Florence., Florence, Italy
Anatomy and Hystology, Spedali Civili di Brescia, University of Brescia.
Brescia, Italy
Pediatric Gastroenterology Unit, IRCCS Gaslini.
Genoa, Italy
Pediatric Gastroenterology Unit, University of Messina.
Messina, Italy
Department of Pediatrics, Ospedali Buzzi.
Milan., Italy
Gastroenterology and Hepatology, University of Pisa.
Pisa, Italy
Unit of Biochemistry and Pharmacology, University of Triest.
Triest, Italy
Sponsors and Collaborators
IRCCS Burlo Garofolo
Ospedale Meyer
Pediatric Gastroenterology Unit, IRCCS Gaslini, Genoa.
Vittore Buzzi Children's Hospital
University of Pisa
University of Messina
Università degli Studi di Brescia
University of Trieste
Study Chair: Alessandro Ventura, MD IRCCS Burlo Garofolo
Study Director: Marzia Lazzerini, MD IRCCS Burlo Garofolo
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Alessandro Ventura, MD, IRCCS Burlo Garofolo Identifier: NCT00720538     History of Changes
Other Study ID Numbers: TAL−005414−20
Study First Received: July 18, 2008
Last Updated: October 25, 2012

Keywords provided by Alessandro Ventura, IRCCS Burlo Garofolo:
Inflammatory bowel diseases.
Crohn disease.
Ulcerative, colitis.
Randomised controlled trial.

Additional relevant MeSH terms:
Crohn Disease
Colitis, Ulcerative
Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Pathologic Processes
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents processed this record on June 22, 2017