Compare Oxycodone, Morphine, and Placebo in Healthy Volunteers;v1.0

• Research type

  Research Study

• Full title

  A Phase I, 5-Period, Randomised, Double-Blind, Crossover Study to Investigate the Pharmacokinetics and Therapeutic Effects of Oxycodone Compared to Morphine and Placebo in Healthy Male Volunteers

• IRAS ID

  52847

• Contact name

  Simon L Singer

• Sponsor organisation

  Shire Pharmaceutical Development Ltd

• Eudract number

  2010-019852-35

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  This will be a randomised, double-blind, placebo-controlled, five period, crossover study in healthy male subjects, conducted using a cold pain model. The study will consist of a screening visit within 28 days prior to Day 1 dosing to confirm subject??s eligibility (visit 1), followed by additional screening visits to assess subject ability to perform the cold pain test reproducibly (visits 2 and 3). There will be five treatment periods during the study; in each treatment period subjects will be confined to the clinical unit from Day 1 until Day 1 (total duration of 2 days confinement in each treatment period). The subjects may be required to stay in the clinical unit overnight on Day 1 if they are feeling unwell. There will be a washout of a minimum of 7 days between the dosing days of each treatment period. Eligibility will be re-confirmed at admission on Day 1 of each treatment period. Each subject will be randomised to one of ten treatment sequences and will receive a single dose of 1mg i.v. oxycodone hydrochloride, 2.5mg i.v. oxycodone hydrochloride, 4mg i.v. oxycodone hydrochloride, 10mg i.v.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  10/IEC03/11

• Date of REC Opinion

  13 May 2010

• REC opinion

  Further Information Favourable Opinion