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

Tracking Information
First Submitted Date ICMJE	April 10, 2007
First Posted Date ICMJE	April 11, 2007
Last Update Posted Date	July 11, 2013
Study Start Date ICMJE	January 2007
Actual Primary Completion Date	October 2011 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: January 20, 2010)	Long term Safety, tolerability and acceptability [ Time Frame: End of study ]
Original Primary Outcome Measures ICMJE; (submitted: April 10, 2007)	Long term Safety; Long term tolerability; Long term Acceptability
Change History	Complete list of historical versions of study NCT00458510 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Long Term Safety Study of Nasalfent (Fentanyl Citrate Nasal Spray) for Treatment of Breakthrough Cancer Pain
Official Title ICMJE	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
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 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.
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 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.
Study Type ICMJE	Interventional
Study Phase	Phase 3
Study Design ICMJE	Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care
Condition ICMJE	Cancers, Pain
Intervention ICMJE	Drug: Fentanyl (Nasalfent, Fentanyl Citrate Nasal Spray); treatment of up to 4 episodes of pain per day; Other Name: FCNS
Study Arms	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)
Publications *	Taylor D, Radbruch L, Revnic J, Torres LM, Ellershaw JE, Perelman MS. Long-term use of fentanyl pectin nasal spray in patients with breakthrough pain in cancer [abstract]. J Clin Oncol. 2013:31(15 Suppl);9563
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: January 20, 2010)	403
Original Enrollment ICMJE	Not Provided
Actual Study Completion Date	July 2012
Actual Primary Completion Date	October 2011 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Not Provided
Removed Location Countries	United States
Administrative Information
NCT Number ICMJE	NCT00458510
Other Study ID Numbers ICMJE	CPO45/06/FCNS
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Archimedes Development Ltd
Study Sponsor ICMJE	Archimedes Development Ltd
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Russell K Portenoy, MD Beth Israel Medical Center, New York, United States
PRS Account	Archimedes Development Ltd
Verification Date	July 2013
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP