Long Term Safety Study of Nasalfent (Fentanyl Citrate Nasal Spray) for Treatment of Breakthrough Cancer Pain
|Cancers, Pain||Drug: Fentanyl (Nasalfent, Fentanyl Citrate Nasal Spray)||Phase 3|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||An Open-Label Study Investigating Long-Term Safety and Tolerability of Fentanyl Citrate Nasal Spray in the Treatment of BTCP in Subjects Taking Regular Opioid Therapy|
- Long term Safety, tolerability and acceptability [ Time Frame: End of study ]
|Study Start Date:||January 2007|
|Study Completion Date:||July 2012|
|Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
Experimental: Fentanyl, Open-Label treatment
All patients take NasalFent at effective dose to treat up to four episodes of breakthrough cancer pain per day
Drug: Fentanyl (Nasalfent, Fentanyl Citrate Nasal Spray)
treatment of up to 4 episodes of pain per day
Other Name: FCNS
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 examine the long-term safety of Nasalfent treatment for breakthrough cancer pain.
After the study is completed, patients may continue to take medication if their doctor feels it is in the patient's best interest to do so. Safety information will continue to be collected during this period. Treatment may continue on study for as long as the patient requires treatment or until Nasalfent becomes commercially available.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00458510
|Principal Investigator:||Russell K Portenoy, MD||Beth Israel Medical Center, New York, United States|