Efficacy of oxycodone/naloxone PR compared to placebo in severe BPS

• Research type

  Research Study

• Full title

  An exploratory, randomised, double-blind, placebo-controlled, parallel group, pilot study to assess the analgesic effect of oxycodone/naloxone prolonged release tablets (OXN PR) compared to placebo in opioid-naive subjects suffering from severe pain due to Bladder Pain Syndrome.

• IRAS ID

  51666

• Contact name

  Andrew Baranowski

• Sponsor organisation

  Mundipharma Research GmbH & Co. KG

• Eudract number

  2009-018118-21

• ISRCTN Number

  N/A

• Research summary

  This is an exploratory Phase II study in 70 female subjects aged 18 and over who suffer from severe pain due to Bladder Pain Syndrome (BPS).The study consists of a 7-14 day screening phase, an 8 week double-blind treatment phase and a follow up telephone or clinic visit 7 days after the last treatment dose. During screening patients will be asked to record their pain over the last 24 hours and micturition (time and volume) over a period of two 24 hour periods. 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. The study medication will be given as additional therapy to the subject's current BPS therapy and subjects will also be dispensed with rescue medication (paracetamol) to help with breakthrough pain. Subjects may be up-titrated if their pain is not controlled to a maximum dose of OXN 40/20 PR twice daily (total daily dose of OXN 80/40 PR). Up-titration of the study medication may take place on every 2nd or 3rd day of treatment if required. The investigator will assess whether the patient requires up-titration during telephone contacts and clinic visits according to the subject's pain values, their intake of rescue medication and responses to various questionnaires and pain scores which will record their pain and overall health, and the results of their micturition and pain diaries. Subjects who consent separately will provide a blood sample for genetic analysis at the end of treatment (visit 10).7 days after the last treatment dose the subject will be contacted by telephone or clinic visit to follow up any ongoing or new adverse events and discuss their ongoing BPS therapy.

• REC name

  North East - York Research Ethics Committee

• REC reference

  10/H0903/30

• Date of REC Opinion

  28 Jul 2010

• REC opinion

  Further Information Favourable Opinion