Cancers, Pain Clinical Trial
Official title:
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
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 painkiller 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 compared to Immediate Release Morphine Sulphate 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
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
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