Extrait

Background and study aims Acute and breakthrough pain (sudden additional acute pain on top of the long-term pain) is difficult to treat, especially since the pain requires immediate relief. Various drugs are available with different timings of pain relief. Here we compare the effect of a new painkiller drug in the form of a melt tablet, OxyNorm instant (oxycodone formulation), with an active placebo (dummy) tablet, a paracetamol melt tablet, to assess the speed of pain relief. Who can participate? The study will be performed in twelve healthy female volunteers, aged 18 to 65. What does the study involve? Pain will be induced experimentally through electrical and pressure pain stimulus. Participants will be randomly allocated to one of two groups. For pain relief, OxyNorm instant will be given to one group and paracetamol to the other. Pain will be recorded over 5 hours following drug intake. Participants are then crossed over (i.e., the treatment is swapped). A mathematical model will be used to analyse the data and get an indication of onset of pain relief. What are the possible benefits and risks of participating? There will be no benefit for the participants. However, it will be useful for treating patients appropriately in future. As the drug doses are low, the risks of the study are minimal and include vomiting and itch. Where is the study run from? The study is run from the Leiden University Medical Center, Netherlands. When is the study starting and how long is it expected to run for? The study started in January 2013 and will run until February 2014. Who is funding the study? Mundipharma Pharmaceuticals BV, Netherlands. Who is the main contact? Prof. Albert Dahan [email protected]

Critère d'inclusion

• Breakthrough Pain

Liens

• ictrp
• isrctn