A Phase 3 interventional study of Fentanyl (Nasalfent, Fentanyl Citrate Nasal Spray) in Cancer Pain, sponsored by Archimedes Development Ltd. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-01-25.
Sponsored by Archimedes Development Ltd · Phase 3, Interventional, and Supportive care
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.
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.
338 studies on the registry are indexed under Cancer Pain; 71 are open to participants now.
This study's enrollment of 73 is above the median of 60 across 254 interventional studies indexed under Cancer Pain.
Browse Cancer Pain studies →Archimedes Development Ltd is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Fentanyl (Nasalfent, Fentanyl Citrate Nasal Spray)
Drug: Fentanyl (Nasalfent, Fentanyl Citrate Nasal Spray)
Summed pain intensity difference at 30 min
Time frame: 30 min after dosing
SPID, Pain intensity, Pain intensity difference, Pain relief and Total pain relief
Time frame: Various timepoints
This study is completed, as verified in Jan 2010. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Archimedes Development Ltd