Efficacy and safety study to compare gabapentin vs tramadol v3.1

• Research type

  Research Study

• Full title

  Randomized, double-blind, double-dummy, active controlled, multicentre, non-inferiority phase-III study to compare the pharmacokinetic, efficacy and safety of gabapentin liquid formulation to tramadol in children from 3 months to less than 18 years of age experiencing moderate to severe chronic neuropathic or mixed pain.

• IRAS ID

  245842

• Contact name

  Daniel Hawcutt

• Contact email

  d.hawcutt@liv.ac.uk

• Sponsor organisation

  PHARM – Pharmaceutical Research Management srl

• Eudract number

  2014-004851-30

• Clinicaltrials.gov Identifier

  NCT02722603

• Clinicaltrials.gov Identifier

  na, na

• Duration of Study in the UK

  2 years, 0 months, 1 days

• Research summary

  The present study is part of a more comprehensive project GAPP (Gabapentin in Paediatric Pain), aimed to address the unmet medical needs in children pain management by providing the necessary clinical information on gabapentin use in paediatric chronic pain (neuropathic and mixed). Indeed, Gabapentin was included in the “Revised priority list for studies into off-patent paediatric medicinal products currently used off-label” (Doc. Ref. EMA/98717/2 012.
  Moreover, the GAPP project plans to test a new liquid oral formulation of drug product appropriately designed for children use.In particular, the present protocol study GABA-1 is intended to assess the efficacy and safety of gabapentin relative to tramadol for the treatment of chronic, neuropathic or mixed pain in the paediatric population.
  The study will be conducted in 14 clinical sites in EU and 6 in extra-EU countries. It will involve a total of 94 patients, 74 in EU and 4 in the UK site. The study is expected to last 22 weeks in UK. The study has been requested and funded by the European Commission (EC-FP7-HEALTH-2013-INNOVATION-1 Grant Agreement n.602962) and EMA (PDCO) approved it (EMA Opinion Number 001310-PIP01-12-M02.1.

• REC name

  Yorkshire & The Humber - Leeds East Research Ethics Committee

• REC reference

  18/YH/0256

• Date of REC Opinion

  8 Oct 2018

• REC opinion

  Further Information Favourable Opinion