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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00458510
Recruitment Status : Completed
First Posted : April 11, 2007
Last Update Posted : July 11, 2013
Information provided by (Responsible Party):
Archimedes Development Ltd

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.

Condition or disease Intervention/treatment Phase
Cancers, Pain Drug: Fentanyl (Nasalfent, Fentanyl Citrate Nasal Spray) Phase 3

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 : Interventional  (Clinical Trial)
Actual Enrollment : 403 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: 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
Study Start Date : January 2007
Primary Completion Date : October 2011
Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Fentanyl, Open-Label treatment
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)
treatment of up to 4 episodes of pain per day
Other Name: FCNS

Primary Outcome Measures :
  1. Long term Safety, tolerability and acceptability [ Time Frame: End of study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00458510

Sponsors and Collaborators
Archimedes Development Ltd
Principal Investigator: Russell K Portenoy, MD Beth Israel Medical Center, New York, United States

Publications of Results:
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

Responsible Party: Archimedes Development Ltd Identifier: NCT00458510     History of Changes
Other Study ID Numbers: CPO45/06/FCNS
First Posted: April 11, 2007    Key Record Dates
Last Update Posted: July 11, 2013
Last Verified: July 2013

Keywords provided by Archimedes Development Ltd:

Additional relevant MeSH terms:
Citric Acid
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action