Know Cancer

or
forgot password

An Open Label, Comparative, Randomised, Balanced Crossover Trial Comparing Nasal Fentanyl and Oral Transmucosal Fentanyl (Actiq®) in Breakthrough Pain in Patients With Cancer


Phase 3
18 Years
N/A
Not Enrolling
Both
Pain

Thank you

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

Name

Location