Status:
COMPLETED
Long Term Safety Study of Nasalfent (Fentanyl Citrate Nasal Spray) for Treatment of Breakthrough Cancer Pain
Lead Sponsor:
Archimedes Development Ltd
Conditions:
Cancers, Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 ...
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...
Eligibility Criteria
Inclusion
- 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
- Intolerance to opioids or fentanyl
- rapidly increasing/uncontrolled pain
- pain that is not cancer related
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
403 Patients enrolled
Trial Details
Trial ID
NCT00458510
Start Date
January 1 2007
End Date
July 1 2012
Last Update
July 11 2013
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