NCT00589823

Efficacy and Safety Study of Nasalfent for Treatment of Breakthrough Cancer Pain in Patients Taking Regular Opioids

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 135 (actual)
• Sponsor: Archimedes Development Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Cancers, Pain

Interventions

Type	Name	Description
DRUG	Fentanyl citrate	nasal spray, 100, 200, 400 or 800 mcg dosage according to need, to treat up to four episodes of BTCP per day
DRUG	Immediate release morphine sulphate	drug dose as required by patient taken to treat up to four epsiodes of BTCP per day

Timeline

• Start date: 2007-06-01
• Primary completion: 2009-03-01
• Completion: 2009-03-01
• First posted: 2008-01-10
• Last updated: 2010-01-22

Locations

1 site across 1 country: United Kingdom