Conversion From Fast Acting Oral Opioids to Abstral® (SL Fentanyl) in Opioid Tolerant Cancer Patients With Breakthrough Pain
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.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response rate in patients converted to SL fentanyl.
A subject is defined as responder if the change of Pain Intensity (PI) on the Numerical Rating Scale (NRS) rated from 0 to 10, at 30 minutes (PID30) is similar or higher after the conversion to SL fentanyl compared to baseline PID30 as assessed by standard care rescue treatment of BTcP episodes.
30 minutes post dose
Anders Pettersson, MD, PhD
Sweden: Medical Products Agency