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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: EUCTR
Last refreshed on: 19 March 2012
Main ID:  EUCTR2005-005414-20-IT
Date of registration: 31/01/2006
Prospective Registration: Yes
Public 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. - Thalidomide and IBD
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. - Thalidomide and IBD
Date of first enrolment: 06/03/2006
Target sample size: 124
Recruitment status: Authorised-recruitment may be ongoing or finished
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no  
Countries of recruitment
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 seven pediatric centres participating in the study. Definition of patient with refractory diseasePatients with active disease despite steroid therapy at a dose 2 mg/kg/die for 8 weeks of prednisone maximum 60mg/day or equivalent 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.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
a Patients with ileostomy or colostomy. b Disease requiring immediate surgical intervention. c Severe ulcerative colitis or toxic megacolon. d Contraindications to using thalidomide on-going pregnancy, neuropathy e 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. f Patients being treated with other drugs as part of an experimental study. g Patients treated with infliximab in the previous eight weeks.

Age minimum:
Age maximum:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Inflammatory Bowel Disease Crohn Disease, Ulcerative Colitis
MedDRA version: 6.1 Level: PT Classification code 10021972

Trade Name: Thalidomide Pharmion
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Thalidomide
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use

Primary Outcome(s)
Main Objective: To evaluate the efficacy and tolerability of thalidomide vs. placebo in children, adolescents, and young adults with untreatable chronic inflammatory bowel disease.
Primary end point(s): Clinical remission for Crohn s disease PCDAI 10 o CDAI 150; for ulcerative colitis UCAI 4. Relapse for Crohn s disease PCDAI 12 o CDAI 180; for ulcerative colitis UCAI 6. Endoscopic response reduction of endoscopic activity scores CDEIS, UCEAI . Side effects Neuropathy/Others resulting in thalidomide suspension/Others.
Secondary Objective: pharmacogenetic study of thalidomide effect
Secondary Outcome(s)
Secondary ID(s)
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Results available:
Date Posted:
Date Completed:
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