Efficacy of OXN PR in severe Parkinson's disease associated pain

• Research type

  Research Study

• Full title

  A multicentre, double-blind, randomised, placebo controlled study to determine the efficacy and tolerability of OXN PR for the treatment of severe Parkinson's disease associated pain

• IRAS ID

  88132

• Contact name

  K Ray Chaudhuri

• Sponsor organisation

  Mundipharma Research GmbH & Co. KG

• Eudract number

  2011-002901-31

• ISRCTN Number

  n/a

• Research summary

  This is a multicentre, double blind randomised, parallel group, Phase III study in 210 subjects aged 25 and over who suffer from Parkinson's Disease associated pain. A sufficient number of subjects will be screened to achieve this number; it is estimated that 250 will be screened. The primary objective of the study is to demonstrate superiority of OXN PR given for analgesia compared to placebo. This will be based on the averaged 24 hour pain scores collected over 7 days prior to each clinic visit and assessed at the end of the 16 week Double-Blind Phase. The study consists of a 7 to 14-day screening phase, an 8-week double blind treatment phase, an up to 4-week optional open label phase and a follow up telephone or clinic visit 7 to 10 days after the last treatment dose. Subjects will be randomised at visit 2 to either oxycodone/naloxone prolonged release (OXN PR) or a matching placebo in a 1:1 ratio if they still meet the eligibility criteria. Subjects will commence the study on a dose of OXN 5/2.5mg PR twice daily, or matching placebo and may be titrated to a maximum daily dose of OXN20/10 mg PR twice daily. Subjects will also be dispensed with rescue medication (levodopa and benserazide hydrochloride combination during the double blind period and Oxycodone Immediate release during the open label phase) to help with breakthrough pain.

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  11/LO/1415

• Date of REC Opinion

  25 Nov 2011

• REC opinion

  Further Information Favourable Opinion