Status:
COMPLETED
Thalidomide in Pediatric Inflammatory Bowel Diseases.
Lead Sponsor:
IRCCS Burlo Garofolo
Collaborating Sponsors:
Ospedale Meyer
Pediatric Gastroenterology Unit, IRCCS Gaslini, Genoa.
Conditions:
Inflammatory Bowel Diseases
Crohn's Disease
Eligibility:
All Genders
2-18 years
Phase:
PHASE3
Brief 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...
Detailed Description
Inflammatory bowel diseases (IBD) are particularly debilitating. They present chronic-recurrent symptoms which often seriously affects the patient's quality of life, acute complications which may need...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT00720538
Start Date
August 1 2008
End Date
June 1 2012
Last Update
October 26 2012
Active Locations (7)
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1
Anatomy and Hystology, Spedali Civili di Brescia, University of Brescia.
Brescia, Brescia, Italy
2
Department of Pediatrics, Ospedale Meyer.
Florence, Florence, Italy
3
Pediatric Gastroenterology Unit, IRCCS Gaslini.
Genoa, Genoa, Italy
4
Pediatric Gastroenterology Unit, University of Messina.
Messina, Messina, Italy