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

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Archimedes Development Ltd
• Treatments: Citric Acid; Fentanyl; Morphine

Criteria

Inclusion Criteria:

• Able and willing to give consent

• Women of childbearing potential must have a) negative urine pregnancy test b) not be breast feeding c) agree to practice a reliable form of contraception

• Diagnosis of cancer

• Taking at least 60mg oral morphine or equivalent as 24 hour treatment for cancer-related pain

• Experiencing on average 1 - 4 episodes of breakthrough cancer pain per day usually controlled by rescue pain medication

• Able (or via caregiver) to evaluate and record pain relief, assess medication performance at set times after dosing, record adverse events, record each use of the study drug or rescue medication in a diary

• Able to be up and about for 50% of the day or greater

Exclusion Criteria:

• Intolerance to opioids or fentanyl

• rapidly increasing/uncontrolled pain

• pain that is not cancer-related