Thalidomide in Pediatric Inflammatory Bowel Diseases. (TALIBDP)
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|ClinicalTrials.gov Identifier: NCT00720538|
Recruitment Status : Completed
First Posted : July 22, 2008
Last Update Posted : October 26, 2012
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 or disease||Intervention/treatment||Phase|
|Inflammatory Bowel Diseases Crohn's Disease Ulcerative Colitis||Drug: Thalidomide Drug: placebo||Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||84 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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.|
|Study Start Date :||August 2008|
|Actual Primary Completion Date :||September 2011|
|Actual Study Completion Date :||June 2012|
Thalidomide 1.5-2.5 mg/kg/die once a day, at evening.
Placebo Comparator: 2
- Clinical Remission [ Time Frame: 8°, 12°, 26, 52° weeks ]
- 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°
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
|Department of Pediatrics, Ospedale Meyer.|
|Florence., Florence, Italy|
|Anatomy and Hystology, Spedali Civili di Brescia, University of Brescia.|
|Pediatric Gastroenterology Unit, IRCCS Gaslini.|
|Pediatric Gastroenterology Unit, University of Messina.|
|Department of Pediatrics, Ospedali Buzzi.|
|Gastroenterology and Hepatology, University of Pisa.|
|Unit of Biochemistry and Pharmacology, University of Triest.|
|Study Chair:||Alessandro Ventura, MD||IRCCS Burlo Garofolo|
|Study Director:||Marzia Lazzerini, MD||IRCCS Burlo Garofolo|