Comparison of Nasal Fentanyl and Oral Transmucosal Fentanyl (Actiq) in Cancer Breakthrough Pain (FT-019-IM)

Nycomed

Status and phase

Completed

Phase 3

Conditions

Pain

Treatments

Drug: Nasal fentanyl

Study type

Interventional

Funder types

Industry

Identifiers

NCT00496392

FT-019-IM

2006-002087-26

Details and patient eligibility

About

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

Enrollment

115 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.