Efficacy & Safety Study of Nasalfent (Fentanyl Citrate Nasal Spray) for Treatment of Breakthrough Cancer Pain in Patients Taking Regular Opioids
Cancer patients taking regular medication for their pain often still have episodes of severe pain that 'break through' despite their background pain treatment. Fentanyl is a strong, short-acting pain killer often used to treat this 'breakthrough' pain. Nasalfent contains fentanyl in a patented drug delivery system called PecSys and is given via a simple nasal spray. This study will test the efficacy and safety of Nasalfent in the treatment of breakthrough cancer pain.
Drug: Fentanyl (Nasalfent, Fentanyl Citrate Nasal Spray)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
|Official Title:||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|
- Summed pain intensity difference at 30 min [ Time Frame: 30 min after dosing ] [ Designated as safety issue: No ]
- SPID, Pain intensity, Pain intensity difference, Pain relief and Total pain relief [ Time Frame: Various timepoints ] [ Designated as safety issue: No ]
|Study Start Date:||December 2006|
|Study Completion Date:||August 2008|
|Primary Completion Date:||July 2008 (Final data collection date for primary outcome measure)|
|Experimental: Nasalfent, Fentanyl Citrate Nasal Spray||Drug: Fentanyl (Nasalfent, Fentanyl Citrate Nasal Spray)|
|Placebo Comparator: Placebo Spray||Drug: Fentanyl (Nasalfent, Fentanyl Citrate Nasal Spray)|
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.
|United States, New York|
|Beth Israel Medical Center|
|New York, New York, United States, 10003|
|Principal Investigator:||Russell K Portenoy, MD||Beth Israel Medical Center|