Trial Information
An Open Label, Comparative, Randomised, Balanced Crossover Trial Comparing Nasal Fentanyl and Oral Transmucosal Fentanyl (Actiq®) in Breakthrough Pain in Patients With Cancer
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Primary endpoint: Time to onset of meaningful pain relief recorded by stopwatch
Outcome Time Frame:
26 weeks
Safety Issue:
Yes
Principal Investigator
Nycomed Clinical Trial Operations
Investigator Role:
Study Chair
Investigator Affiliation:
Headquaters
Authority:
France: Ministry of Health
Study ID:
FT-019-IM
NCT ID:
NCT00496392
Start Date:
January 2007
Completion Date:
October 2009
Related Keywords:
- Pain
- breakthrough pain in patients with cancer
