GAbapentin in Paediatric Pain

akronüüm: GAPP
algus: 2013-07-01
lõpp: 2017-06-30
 
programm: FP7 - Euroopa Liidu 7. raamprogramm
alaprogramm: HEALTH - Tervis
instrument: CP-FP - Väikese- ja keskmisemahulised koostööprojektid
projektikonkurss: FP7-HEALTH-2013-INNOVATION-1
projekti number: 602962
kestus kuudes: 48
partnerite arv: 15
 
lühikokkuvõte: Chronic pain is estimated to affect 15-20% of children with varying disabilities. Due to the paucity of clinical information and appropriate medicinal products, in clinical practice paediatric patients are often under-treated causing profound impact on their QoL. To date, opioids, non-steroid anti-inflammatory drugs (NSAIDs), antidepressants and anticonvulsants are used to treat pain, but only few of these include a paediatric authorisation. In addition, the few available paediatric drugs have a very different authorisation profile across Europe and, when not approved in paediatrics, they are used off-label to cover the high therapeutic need, thus exposing children to unnecessary risks of dosing errors and increasing ADRs. The GAPP Project is focused on the development of gabapentin for the treatment of paediatric chronic pain, a condition where gabapentin, as demonstrated in adults, is expected to bring great benefit to children. To this end, a large international scientific Consortium is set up, with experienced professionals in the field of pain that will work together with a Pharmaceutical Company committed to apply for a PUMA using the project results. Within GAPP, an age-appropriate formulation will be developed and two randomised, comparator-controlled clinical trials and a bridging study will be conducted in compliance to a submitted Paediatric Investigation Plan (PIP, Summary Report Day 90 - EMEA-001310-PIP01-12) in order to investigate appropriate dosages, efficacy and safety of gabapentin in the paediatric population. At the end of the project, gabapentin can be proposed for treatment of chronic pain in children both as monotherapy and as adjuvant therapy. In conclusion, the development plan proposed in the GAPP project is expected to cover the existing therapeutic gap in paediatrics, as recommended in the EMA-PDCO Priority List and in the recent “WHO guidelines on the pharmacological treatment of persisting pain in children with medical illnesses”.
partneri jrk nr ja roll partneri nimi riik kontaktisik koduleht
1 koordinaator CONSORZIO PER VALUTAZIONI BIOLOGICHE E FARMACOLOGICHE IT Donato Bonifazi http://www.cvbf.net
2 partner ERASMUS UNIVERSITAIR MEDISCH CENTRUM ROTTERDAM NL Saskia de Wildt http://www.erasmusmc.nl
3 partner FONDAZIONE PENTA-FOR THE TREATMENT AND CARE OF CHILDREN WITH HIV-ONLUS IT Carlo Giaquinto
4 partner SOCIETA SERVIZI TELEMATICI SRL IT Luigi Cantarutti
5 partner AZIENDA OSPEDALIERO UNIVERSITARIA CONSORZIALE POLICLINICO DI BARI IT Lucia Margari
6 partner Pharmaceutical Research Management Srl IT Laura Mangiarini http://www.pharmsrl.com
7 partner Tartu Ülikooli Kliinikum SA EE Vallo Tillmann http://www.kliinikum.ee/
8 partner DOMPE SPA IT Marco Maria Gentile http://www.dompe.it
9 partner UNIVERSITY COLLEGE LONDON UK Oscar Della Pasqua http://www.ucl.ac.uk
10 partner UNIVERSITAETSKLINIKUM ERLANGEN DE Regina Trollmann http://www.uk-erlangen.de
11 partner QENDER SPITALORE UNIVERSITARE NENEA TIRANE AL Elmira Kola
12 partner ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS FR Florentia Kaguelidou http://www.aphp.fr
13 partner CONFEDERACION INTERNACIONAL DE ORGANIZACIONES DE PADRES DE NINOS CON CANCER ASOCIACION ES Patricia Brouwer http://www.icccpo.org
14 partner ISTITUTO GIANNINA GASLINI IT Luca Manfredini http://www.gaslini.org
15 partner "Agia Sofia" Children's Hospital EL Giouli Mammi http://www.paidon-agiasofia.gr