Thalidomide in Pediatric Inflammatory Bowel Diseases. (TALIBDP)
This study has been completed.
Sponsor:
IRCCS Burlo Garofolo
Collaborators:
Ospedale Meyer
Pediatric Gastroenterology Unit, IRCCS Gaslini, Genoa.
Vittore Buzzi Children's Hospital
University of Pisa
Pediatric Gastroenterology Unit, University of Messina.
Brescia University
University of Trieste
Information provided by (Responsible Party):
Alessandro Ventura, IRCCS Burlo Garofolo
ClinicalTrials.gov Identifier:
NCT00720538
First received: July 18, 2008
Last updated: October 25, 2012
Last verified: October 2012
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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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 IRCCS Burlo Garofolo:
Primary Outcome Measures:
- Clinical Remission [ Time Frame: 8°, 12°, 26, 52° weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Clinical response [ Time Frame: 4°, 8° weeks ] [ Designated as safety issue: No ]
- Steroid dose reduction [ Time Frame: 8°, 12°, 26, 52° weeks ] [ Designated as safety issue: No ]
- Endoscopic remission [ Time Frame: 12°, 26, 52° weeks ] [ Designated as safety issue: No ]
- Adverse effects [ Time Frame: 4°, 8°, 12°, 26, 52° weeks ] [ Designated as safety issue: Yes ]
- Nutritinal indicators [ Time Frame: 8°, 52° ] [ Designated as safety issue: No ]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:
|
|
Placebo Comparator: 2
Placebo
|
Drug: placebo
placebo capsules
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 2 Years to 18 Years |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: 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
Pediatric Gastroenterology Unit, University of Messina.
Brescia University
University of Trieste
Investigators
| Study Chair: | Alessandro Ventura, MD | IRCCS Burlo Garofolo |
| Study Director: | Marzia Lazzerini, MD | IRCCS Burlo Garofolo |
More Information
Publications:
| Responsible Party: | Alessandro Ventura, MD, IRCCS Burlo Garofolo |
| ClinicalTrials.gov Identifier: | NCT00720538 History of Changes |
| Other Study ID Numbers: | TAL−005414−20 |
| Study First Received: | July 18, 2008 |
| Last Updated: | October 25, 2012 |
| Health Authority: | Italy: Ministry of Health Italy: National Monitoring Centre for Clinical Trials - Ministry of Health Italy: Agenzia Italiana del Farmaco (AIFA ) Funds for Industry-Indipendent Research (contract with sponsor signed in September 2007) |
Keywords provided by IRCCS Burlo Garofolo:
|
Inflammatory bowel diseases. Crohn disease. Ulcerative, colitis. Randomised controlled trial. |
Therapy. Thalidomide. Children. |
Additional relevant MeSH terms:
|
Colitis Colitis, Ulcerative Crohn Disease Inflammatory Bowel Diseases Intestinal Diseases Ulcer Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Colonic Diseases Pathologic Processes Thalidomide Immunosuppressive Agents |
Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Leprostatic Agents Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 23, 2013