Recruitment difficulties

The purpose of this study is to evaluate safety and efficacy when using a novel dose conversion strategy to switch from immediate release oral opioids to sublingual (SL) fentanyl (Abstral) for treatment of breakthrough cancer pain (BTcP).

The study aims to show that in the advanced stage of cancer the individual patient already on high doses of BTcP medication will benefit from starting treatment on a higher first dose of SL fentanyl thus reducing the number of dosing steps with insufficient pain relief.

Inclusion Criteria:

• Signed informed consent obtained.
• 18 years or older, of both genders.
• Opioid tolerant patients
• Estimated frequency of BTcP 0.5-4 times a day.

Exclusion Criteria:

• Treatment with SL fentanyl within two weeks prior to screening.
• Recent or planned therapy that would alter pain or responses to analgesics.
• Treatment with monoamine oxidase inhibitor < 14 days before or concurrent with SL fentanyl treatment.
• Significantly reduced liver and/or kidney function.
• Significant prior history of substance abuse.
• Pregnancy, breast feeding or woman of childbearing potential not using adequate birth control.