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GAbapentin in Paediatric Pain

Obiettivo

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.

Invito a presentare proposte

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Coordinatore

CONSORZIO PER VALUTAZIONI BIOLOGICHE E FARMACOLOGICHE
Indirizzo
Via Nicolo Putignani 178
70122 Bari
Italia
Tipo di attività
Research Organisations
Contributo UE
€ 1 224 676,25
Contatto amministrativo
Donato Bonifazi (Mr.)

Partecipanti (15)

DOMPE SPA

Partecipazione conclusa

Italia
Indirizzo
Via Campo Di Pile
67100 L'aquila
Tipo di attività
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Contatto amministrativo
Cinzia D'ettore (Dr.)
ERASMUS UNIVERSITAIR MEDISCH CENTRUM ROTTERDAM
Paesi Bassi
Contributo UE
€ 438 138,50
Indirizzo
Dr Molewaterplein 40
3015 GD Rotterdam
Tipo di attività
Higher or Secondary Education Establishments
Contatto amministrativo
Ellen Schenk
FONDAZIONE PENTA - FOR THE TREATMENT AND CARE OF CHILDREN WITH HIV ANDRELATED DISEASES - ONLUS
Italia
Contributo UE
€ 367 088,75
Indirizzo
Corso Stati Uniti 4
35127 Padova
Tipo di attività
Research Organisations
Contatto amministrativo
Luigi Comacchio (Mr.)
SOCIETA SERVIZI TELEMATICI SRL
Italia
Contributo UE
€ 359 000
Indirizzo
Via Giacomo Medici
35138 Padova
Tipo di attività
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Contatto amministrativo
Luigi Cantarutti (Dr.)
AZIENDA OSPEDALIERO UNIVERSITARIA CONSORZIALE POLICLINICO DI BARI
Italia
Contributo UE
€ 136 690,50
Indirizzo
Piazza Giulio Cesare 11
70124 Bari
Tipo di attività
Higher or Secondary Education Establishments
Contatto amministrativo
Maria Domenica Lippolis (Dr.)
PHARM - PHARMACEUTICAL RESEARCH MANAGEMENT SRLIN SRL
Italia
Contributo UE
€ 647 200
Indirizzo
Via Einstein Snc
26900 Lodi Lo
Tipo di attività
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Contatto amministrativo
Laura Mangiarini (Dr.)
SIHTASUTUS TARTU ULIKOOLI KLIINIKUM
Estonia
Contributo UE
€ 156 540,50
Indirizzo
Puusepa 1A
50406 Tartu
Tipo di attività
Research Organisations
Contatto amministrativo
Inga Talvik (Dr.)
DOMPE FARMACEUTICI SPA
Italia
Contributo UE
€ 713 500
Indirizzo
Via S Martino Della Battaglia 12
20122 Milano
Tipo di attività
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Contatto amministrativo
Cinzia D'ettore (Dr.)
UCL Elizabeth Garrett Anderson Institute for Women’s Health
United Kingdom
Contributo UE
€ 260 300
Indirizzo
Gower Street
WC1E 6BT London
Tipo di attività
Higher or Secondary Education Establishments
Contatto amministrativo
Kamilla Kolasinska (Ms.)
UNIVERSITATSKLINIKUM ERLANGEN
Germania
Contributo UE
€ 181 918
Indirizzo
Maximiliansplatz 2
91054 Erlangen
Tipo di attività
Higher or Secondary Education Establishments
Contatto amministrativo
Katrin Faber (Dr.)
QENDRES SPITALORE UNIVERSITARE NENETEREZA TIRANE
Albania
Contributo UE
€ 164 455
Indirizzo
Rr Dibres 370
1001 Tirana
Tipo di attività
Higher or Secondary Education Establishments
Contatto amministrativo
Dollani Mirjel (Dr.)
ASSISTANCE PUBLIQUE HOPITAUX DE PARIS
Francia
Contributo UE
€ 450 320,50
Indirizzo
3 Avenue Victoria
75000 Paris
Tipo di attività
Research Organisations
Contatto amministrativo
Alix Pillot (Ms.)
CONFEDERACION INTERNACIONAL DE ORGANIZACIONES DE PADRES DE NINOS CON CANCER ASOCIACION
Spagna
Contributo UE
€ 49 000
Indirizzo
Plaza Pablo Picasso 9 3 D
46015 Valencia
Tipo di attività
Other
Contatto amministrativo
Patricia Brouwer (Dr.)
ISTITUTO GIANNINA GASLINI
Italia
Contributo UE
€ 148 791,25
Indirizzo
Via Gerolamo Gaslini 5
16147 Genova
Tipo di attività
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Contatto amministrativo
Maria Gabriella Marinari (Mrs.)
GENIKO NOSOKOMEIO PAIDON ΑTHINON I AGIA SOPHIA - PAIDON PENTELIS
Greece
Contributo UE
€ 179 255,75
Indirizzo
Thivon And Papadiamantopoulou 1
115 27 Athina
Tipo di attività
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Contatto amministrativo
Eleana Garini (Dr.)