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Thalidomide in Pediatric Inflammatory Bowel Diseases. (TALIBDP)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00720538
First Posted: July 22, 2008
Last Update Posted: October 26, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
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
  Purpose

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: Quadruple (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
Thalidomide
Drug: Thalidomide
Thalidomide 1.5-2.5 mg/kg/die once a day, at evening.
Other Names:
  • Thalidomide PHARMION
  • Thalidomid CELGENE
Placebo Comparator: 2
Placebo
Drug: placebo
placebo capsules

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00720538


Locations
Italy
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
Investigators
Study Chair: Alessandro Ventura, MD IRCCS Burlo Garofolo
Study Director: Marzia Lazzerini, MD IRCCS Burlo Garofolo
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Alessandro Ventura, MD, IRCCS Burlo Garofolo
ClinicalTrials.gov Identifier: NCT00720538     History of Changes
Other Study ID Numbers: TAL−005414−20
First Submitted: July 18, 2008
First Posted: July 22, 2008
Last Update Posted: October 26, 2012
Last Verified: October 2012

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

Additional relevant MeSH terms:
Crohn Disease
Colitis
Ulcer
Colitis, Ulcerative
Intestinal Diseases
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Pathologic Processes
Thalidomide
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