Overview

Efficacy & Safety Study of Nasalfent (Fentanyl Citrate Nasal Spray) for Treatment of Breakthrough Cancer Pain in Patients Taking Regular Opioids

Status:
Completed
Trial end date:
2008-08-01
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 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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Archimedes Development Ltd
Treatments:
Citric Acid
Fentanyl
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