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

NCT00458510 | Completed Phase 3

• 1 other identifier: CPO45/06/FCNS
• Study Type: interventional
• Target: 403
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cancers, Pain

Keywords

Pain; Cancer; Breakthrough

Outcome Measures

Primary Outcomes (1)

• Long term Safety, tolerability and acceptability

  End of study

Study Arms (1)

Fentanyl, Open-Label treatment

EXPERIMENTAL

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)

Interventions

Fentanyl (Nasalfent, Fentanyl Citrate Nasal Spray) DRUG

treatment of up to 4 episodes of pain per day

Also known as: FCNS

Fentanyl, Open-Label treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Intolerance to opioids or fentanyl
• rapidly increasing/uncontrolled pain
• pain that is not cancer related

Sponsors & Collaborators

• Archimedes Development Ltd: lead

Related Publications (1)

• 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

  RESULT

MeSH Terms

Conditions

Neoplasms; Pain

Interventions

Fentanyl

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Russell K Portenoy, MD

  Beth Israel Medical Center, New York, United States

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2007
• First Posted: April 11, 2007
• Study Start: January 1, 2007
• Primary Completion: October 1, 2011
• Study Completion: July 1, 2012
• Last Updated: July 11, 2013

Record last verified: 2013-07