Pain
Conditions
Keywords
breakthrough pain in patients with cancer
Brief summary
Primary: • To compare the efficacy of nasal fentanyl (NF) to oral transmucosal fentanyl (Actiq®) (hereafter Actiq) in the management of breakthrough pain in cancer patients. Secondary: * To compare patients' general impression and preference of NF and Actiq * To explore the relationship between NF doses and dose of current opioid for breakthrough pain (BTP) and the relationship between dose of NF and of background opioid * To assess safety and tolerability of NF
Interventions
DRUGNasal fentanyl
Breakthrough pain in patients with breast or prostate cancer
Sponsors
Nycomed
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult in- or out patient with cancer and breakthrough pain; using a stable, chronic opioid treatment for background pain. * Minimum three BTP episodes per week and maximum four per day. Life expectancy of at least three months. * Chemotherapy and palliative radiotherapy (except facial radiotherapy) are allowed. * Randomisation in previous studies with NF, i.e. FT-016-IM, FT-017-IM or FT-018-IM, is not allowed. * Previous use of Actiq is accepted.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint: Time to onset of meaningful pain relief recorded by stopwatch | 26 weeks |
Secondary
| Measure | Time frame |
|---|---|
| • Pain Intensity Differences (PID) at 10 and 30 min derived from Pain Intensity (PI) scores • Sum of Pain Intensity Differences (SPID) 0-15 and 0-60 derived from PI scores • Time to 50% reduction in PI scores • General impression (GI) of the t | 26 weeks |
Countries
Denmark
Outcome results
None listed