A Multicentre, Double-Blind, Double-Dummy, Two-Phase Crossover Study of Fentanyl Citrate Nasal Spray Compared to Immediate Release Morphine Sulphate in the Treatment of 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
many 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
Immediate Release Morphine Sulphate. The safety of the two treatment options 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
Pain Relief
Various time points
No
Marie Fallon
Principal Investigator
Western General Hospital, Edinburgh Cancer Centre
Czech Republic: Ethics Committee
CPO44/06/FCNS
NCT00589823
June 2007
March 2009
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