Long Term Safety Study of Nasalfent (Fentanyl Citrate Nasal Spray) for Treatment of Breakthrough Cancer Pain in Patients Taking Regular Opioid Therapy

Condition(s) targeted: Cancer Pain

Intervention: Fentanyl (Nasalfent, Fentanyl Citrate Nasal Spray) (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Archimedes Development Ltd

Official(s) and/or principal investigator(s):
Russell K Portenoy, MD, Principal Investigator, Affiliation: Beth Israel Medical Center, New York, United States

Overall contact:
Judy Schmidtberger, Phone: 913 904 5042, Email: judy.schmidtberger@i3research.com

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.

Official title: An Open-Label Study Investigating Long-Term Safety and Tolerability of Nasalfent (Fentanyl Citrate Nasal Spray) in the Treatment of Breakthrough Cancer Pain (BTCP) in Subjects Taking Regular Opioid Therapy

Study design: Supportive Care, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

Primary outcome:

Long term Safety

Long term tolerability

Long term Acceptability

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Judy Schmidtberger, Phone: 913 904 5042, Email: judy.schmidtberger@i3research.com

Beth Israel Medical Center, New York, New York 10003, United States; Recruiting

Starting date: January 2007
Ending date: February 2009
Last updated: January 12, 2009