An Open Label, Comparative, Randomised, Balanced Crossover Trial Comparing Nasal Fentanyl and Oral Transmucosal Fentanyl (Actiq®) in Breakthrough Pain in Patients With Cancer
- 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
- Previous use of Actiq is accepted.
Type of Study:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary endpoint: Time to onset of meaningful pain relief recorded by stopwatch
Outcome Time Frame:
Nycomed Clinical Trial Operations
France: Ministry of Health
- breakthrough pain in patients with cancer