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Long Term Safety Study of Nasalfent (Fentanyl Citrate Nasal Spray) for Treatment of Breakthrough Cancer Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Archimedes Development Ltd
ClinicalTrials.gov Identifier:
NCT00458510
First received: April 10, 2007
Last updated: January 25, 2013
Last verified: January 2013
History of Changes

April 10, 2007
January 25, 2013
January 2007
October 2011   (final data collection date for primary outcome measure)
Long term Safety, tolerability and acceptability [ Time Frame: End of study ] [ Designated as safety issue: Yes ]
  • Long term Acceptability
  • Long term Safety
  • Long term tolerability
Complete list of historical versions of study NCT00458510 on ClinicalTrials.gov Archive Site
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Long Term Safety Study of Nasalfent (Fentanyl Citrate Nasal Spray) for Treatment of Breakthrough Cancer Pain
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

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 examine the long-term safety of Nasalfent in the treatment of breakthrough cancer pain.

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.
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Cancers, Pain
Drug: Fentanyl (Nasalfent, Fentanyl Citrate Nasal Spray)
treatment of up to 4 episodes of pain per day
Other Name: FCNS
Experimental: Fentanyl, Open-Label treatment
All patients take NasalFent at effective dose to treat up to four episodes of breakthrough cancer pain per day
Intervention: Drug: Fentanyl (Nasalfent, Fentanyl Citrate Nasal Spray)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
403
July 2012
October 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00458510
CPO45/06/FCNS
No
Archimedes Development Ltd
Archimedes Development Ltd
Not Provided
Principal Investigator: Russell K Portenoy, MD Beth Israel Medical Center, New York, United States
Archimedes Development Ltd
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP