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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT00720538
Date of registration: 18/07/2008
Prospective Registration: Yes
Primary sponsor: IRCCS Burlo Garofolo
Public title: Thalidomide in Pediatric Inflammatory Bowel Diseases. TALIBDP
Scientific 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.
Date of first enrolment: August 2008
Target sample size: 84
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT00720538
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment  
Phase:  Phase 3
Countries of recruitment
Italy
Contacts
Name:     Alessandro Ventura, MD
Address: 
Telephone:
Email:
Affiliation:  IRCCS Burlo Garofolo
Name:     Marzia Lazzerini, MD
Address: 
Telephone:
Email:
Affiliation:  IRCCS Burlo Garofolo
Key inclusion & exclusion 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.



Age minimum: 2 Years
Age maximum: 18 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Crohn's Disease
Inflammatory Bowel Diseases
Ulcerative Colitis
Intervention(s)
Drug: placebo
Drug: Thalidomide
Primary Outcome(s)
Clinical Remission [Time Frame: 8°, 12°, 26, 52° weeks]
Secondary Outcome(s)
Adverse effects [Time Frame: 4°, 8°, 12°, 26, 52° weeks]
Clinical response [Time Frame: 4°, 8° weeks]
Endoscopic remission [Time Frame: 12°, 26, 52° weeks]
Nutritinal indicators [Time Frame: 8°, 52°]
Steroid dose reduction [Time Frame: 8°, 12°, 26, 52° weeks]
Secondary ID(s)
TAL-005414-20
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ospedale Meyer
Pediatric Gastroenterology Unit, IRCCS Gaslini, Genoa.
Pediatric Gastroenterology Unit, University of Messina.
Università degli Studi di Brescia
University of Pisa
University of Trieste
Vittore Buzzi Children's Hospital
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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