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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Cancers, Pain

Intervention / Treatment
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* Drug: Fentanyl (Nasalfent, Fentanyl Citrate Nasal Spray)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fentanyl, Open-Label treatment<br>All patients take NasalFent at effective dose to treat up to four episodes of breakthrough cancer pain per day | Drug: Fentanyl (Nasalfent, Fentanyl Citrate Nasal Spray)<br>* treatment of up to 4 episodes of pain per day<br>* Other names: FCNS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long term Safety, tolerability and acceptability |  | End of study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, Cancer, Breakthrough