A Multicenter, Placebo-Controlled, Double-Blind, Two-Phase Crossover Study of Nasalfent (Fentanyl Citrate Nasal Spray) in the Treatment of Breakthrough Cancer Pain (BTCP) in Subjects Taking Regular Opioid Therapy
Current treatments for breakthrough cancer pain (BTCP) work too slowly to meet the fast
onset of most BTCP episodes, they continue to act longer than the episode of pain lasts and
so can have unwanted side effects due to this 'over treatment' of the pain episode. In
addition most cancer patients have oral problems which make taking pain relief medication by
mouth uncomfortable for the patient. Nasalfent is administered via the nose as a simple
spray and can be taken by patients or given by their carers. The nasal route is a common
way to administer medication for example in the treatment of migraine or allergy. At any
time during the study the patient may take their regular treatment for BTCP should they so
wish.
This study will compare the time of onset and degree of pain relief of Nasalfent to that of
Placebo. The safety of the two treatments groups (Nasalfent, Placebo) will also be
examined.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
Summed pain intensity difference at 30 min
30 min after dosing
No
Russell K Portenoy, MD
Principal Investigator
Beth Israel Medical Center
United States: Food and Drug Administration
CPO43/06/FCNS
NCT00459277
December 2006
August 2008
Name | Location |
---|---|
Beth Israel Medical Center | New York, New York 10003 |