GAPP
GAbapentin in Paediatric Pain
| Coordinatore | CONSORZIO PER VALUTAZIONI BIOLOGICHE E FARMACOLOGICHE
Organization address
address: VIA LUIGI PORTA 14 contact info |
| Nazionalità Coordinatore | Italy [IT] |
| Totale costo | 7˙189˙924 € |
| EC contributo | 5˙476˙875 € |
| Programma | FP7-HEALTH
Specific Programme "Cooperation": Health |
| Code Call | FP7-HEALTH-2013-INNOVATION-1 |
| Funding Scheme | CP-FP |
| Anno di inizio | 2013 |
| Periodo (anno-mese-giorno) | 2013-07-01 - 2017-06-30 |
Partecipanti
| # | ||||
|---|---|---|---|---|
| 1 |
CONSORZIO PER VALUTAZIONI BIOLOGICHE E FARMACOLOGICHE
Organization address
address: VIA LUIGI PORTA 14 contact info |
IT (PAVIA) | coordinator | 1˙224˙676.25 |
| 2 |
DOMPE FARMACEUTICI SPA
Organization address
address: VIA S MARTINO DELLA BATTAGLIA 12 contact info |
IT (MILANO) | participant | 713˙500.00 |
| 3 |
PHARM - PHARMACEUTICAL RESEARCH MANAGEMENT SRLIN SRL
Organization address
address: VIA EINSTEIN SNC contact info |
IT (LODI LO) | participant | 647˙200.00 |
| 4 |
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS
Organization address
address: 3 Avenue Victoria contact info |
FR (PARIS) | participant | 450˙320.50 |
| 5 |
ERASMUS UNIVERSITAIR MEDISCH CENTRUM ROTTERDAM
Organization address
address: 's Gravendijkwal 230 contact info |
NL (ROTTERDAM) | participant | 438˙138.50 |
| 6 |
FONDAZIONE PENTA-FOR THE TREATMENT AND CARE OF CHILDREN WITH HIV-ONLUS
Organization address
address: CORSO STATI UNITI 4 contact info |
IT (PADOVA) | participant | 367˙088.75 |
| 7 |
SOCIETA SERVIZI TELEMATICI SRL
Organization address
address: VIA MEDICI GIACOMO 9/A contact info |
IT (PADOVA) | participant | 359˙000.00 |
| 8 |
UNIVERSITY COLLEGE LONDON
Organization address
address: GOWER STREET contact info |
UK (LONDON) | participant | 260˙300.00 |
| 9 |
UNIVERSITATSKLINIKUM ERLANGEN
Organization address
address: Maximiliansplatz 2 contact info |
DE (ERLANGEN) | participant | 181˙918.00 |
| 10 |
GENIKO NOSOKOMEIO PAIDON ?THINON I AGIA SOPHIA - PAIDON PENTELIS
Organization address
address: THIVON AND PAPADIAMANTOPOULOU 1 contact info |
EL (ATHINA) | participant | 179˙255.75 |
| 11 |
QENDER SPITALORE UNIVERSITARE NENEA TIRANE
Organization address
address: RR DIBRES 370 contact info |
AL (TIRANA) | participant | 164˙455.00 |
| 12 |
SIHTASUTUS TARTU UELIKOOLI KLIINIKUM
Organization address
address: PUUSEPA 1A contact info |
EE (TARTU) | participant | 156˙540.50 |
| 13 |
ISTITUTO GIANNINA GASLINI
Organization address
address: VIA GEROLAMO GASLINI 5 contact info |
IT (GENOVA) | participant | 148˙791.25 |
| 14 |
AZIENDA OSPEDALIERO UNIVERSITARIA CONSORZIALE POLICLINICO DI BARI
Organization address
address: PIAZZA GIULIO CESARE 11 contact info |
IT (BARI) | participant | 136˙690.50 |
| 15 |
CONFEDERACION INTERNACIONAL DE ORGANIZACIONES DE PADRES DE NINOS CON CANCER ASOCIACION
Organization address
address: PLAZA PABLO PICASSO 9 3 D contact info |
ES (VALENCIA) | participant | 49˙000.00 |
| 16 |
DOMPE SPA
Organization address
address: Via Campo di Pile contact info |
IT (L'Aquila) | participant | 0.00 |
Mappa
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Obiettivo del progetto (Objective)
'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, 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. Further to this, in order to ensure the safety of gabapentin in very young children, a non clinical study will be conducted to evaluate the neurotoxic potentil of the drug. At the end of the project, gabapentin can be proposed for treatment of chronic pain in children both as monotherapy and as adjuvant therapy.'