Oral transmucosal opioid pharmacokinetics (Vers 1)

• Research type

  Research Study

• Full title

  Investigation into the impact of salivary gland dysfunction on the pharmacokinetics of oral transmucosal opioids for breakthrough cancer pain (BTcP)

• IRAS ID

  21713

• Contact name

  Andrew Davies

• Eudract number

  2009-013873-17

• ISRCTN Number

  N/A

• Research summary

  The aim of this study is to evaluate the performance of oral transmucosal opioids (strong pain killers that are absorbed through the lining of the mouth) in cancer patients with salivary gland dysfunction. There are 2 recently licensed products (Abstral and Effentora) for the treatment of breakthrough cancer pain (sudden flare ups of pain in patients with stable background pain). These painkillers work quickly as they are fentanyl preparations which are absorbed into the body through the lining of the mouth. In order for them to work it is necessary for saliva to cause them to dissolve. It is known that cancer patients often have reduced saliva for a variety of reasons. There is no data looking at these products in patients with reduced saliva. We believe that they will not work as quickly or as well in this group of patients. It is important to find this out so they can be prescribed appropriately. We intend to administer these products to cancer patients with reduced saliva and test the blood levels to see how quickly the medication gets into the blood stream. We will repeat this test after the patient has had a sip of water to see if this makes a difference, and also after the patient has had a treatment to increase the amount of saliva in their mouth. There will be 3 days between each test so the study will take 6 days. The patients we recruit will have to have a cancer diagnosis and already be on strong painkillers for treatment of their pain. They will be in a hospital ward for the day of the study with monitoring equipment and a doctor present.

• REC name

  London - Westminster Research Ethics Committee

• REC reference

  09/H0802/89

• Date of REC Opinion

  20 Aug 2009

• REC opinion

  Further Information Favourable Opinion