An Open-Label Study Investigating Long-Term Safety and Tolerability of Fentanyl Citrate Nasal Spray in the Treatment of BTCP in Subjects Taking Regular Opioid Therapy
18 Years
N/A
Both
Cancers, Pain
Trial Information
An Open-Label Study Investigating Long-Term Safety and Tolerability of Fentanyl Citrate Nasal Spray in the Treatment of BTCP in Subjects Taking Regular Opioid Therapy
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 most 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 examine the long-term safety of Nasalfent treatment for breakthrough cancer
pain.
After the study is completed, patients may continue to take medication if their doctor feels
it is in the patient's best interest to do so. Safety information will continue to be
collected during this period. Treatment may continue on study for as long as the patient
requires treatment or until Nasalfent becomes commercially available.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
Long term Safety, tolerability and acceptability
Outcome Time Frame:
End of study
Safety Issue:
Yes
Principal Investigator
Russell K Portenoy, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Beth Israel Medical Center, New York, United States
Authority:
United States: Food and Drug Administration
Study ID:
CPO45/06/FCNS
NCT ID:
NCT00458510
Start Date:
January 2007
Completion Date:
July 2012
Related Keywords:
- Cancers, Pain
- Pain
- Cancer
- Breakthrough
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