RELIEVE-1 Study

• Research type

  Research Study

• Full title

  A randomised, double-blind, placebo-controlled study to evaluate the efficacy of two different dose levels of orvepitant (10 and 30 mg) compared with placebo on EGFRi-induced intense pruritus in oncology subjects (The “RELIEVE 1” Study)

• IRAS ID

  156749

• Contact name

  Elizabeth Ruth Plummer

• Contact email

  Ruth.Plummer@newcastle.ac.uk

• Sponsor organisation

  NeRRe Therapeutics Ltd

• Eudract number

  2013-002763-25

• Research summary

  This will be multi-centre, randomised, placebo- controlled, double- blind study evaluating the efficacy of multiple dosing with the highly potent and selective neurokinin (NK)-1 receptor antagonist orvepitant in oncology subjects for the treatment of pruritus inducted by drugs that target the inhibition of the epidermal growth factor receptor (EGFR). The proposed clinical study will be conducted to investigate the effect of orvepitant on EGFR inhibitor (EGFRi)- induced intense pruritus in oncology subjects. The evalutation will be based on
  NRS-IVRS system, with daily records and on the evaluation of the quality of life during the clinic visit.

• REC name

  North East - Tyne & Wear South Research Ethics Committee

• REC reference

  14/NE/1079

• Date of REC Opinion

  9 Sep 2014

• REC opinion

  Further Information Favourable Opinion