A Dose Titrated Clinical Trial With a Placebo-controlled, Double-blind, Randomised, Cross-over Phase to Demonstrate the Efficacy of 400 μg Intranasal Fentanyl (INFS) Dose Strength, and to Evaluate 12 Weeks Safety and Nasal Tolerability of All Dose Strengths Between 50 μg and 400 μg, in Cancer Patients With Breakthrough Pain.
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Pain intensity difference at 10 minutes (PID10) after treatment with 400µg INFS
The primary outcome measure will be analysed based on data collected in the efficacy phase (II). During the efficacy phase patients must assess their pain intensity of each of the investigational medicinal product (IMP) treated breakthrough pain (BTP) episode at 10 minutes after first dose of IMP; using the 11-point Numerical Rating Scale (NRS) from 0 to 10, where 0 represents the absence of pain and 10 is "worst possible pain". PID10 is calculated as the difference in pain intensity from time 0 to 10 minutes PID10. A positive value is a decrease (improvement) of the pain.
During the efficacy phase (II) [= treatment of 8 BTP episodes]
Hungary: National Institute of Pharmacy