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OpenTrials
Completed

NCT Number: NCT00589823

Efficacy and Safety Study of Nasalfent for Treatment of Breakthrough Cancer Pain in Patients Taking Regular Opioids

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 painkiller 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 test the efficacy and safety of Nasalfent compared to Immediate Release Morphine Sulphate in the treatment of breakthrough cancer pain.

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Key information

Conditions

Cancers, Pain Neoplasms Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Prof Fallon

Edinburgh, United Kingdom

About this study

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 many 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 compare the time of onset and degree of pain relief of Nasalfent to that of Immediate Release Morphine Sulphate. The safety of the two treatment options will also be examined.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fentanyl Citrate

Drug

nasal spray, 100, 200, 400 or 800 mcg dosage according to need, to treat up to four episodes of BTCP per day

Other names: FCNS, Nasalfent

Immediate release morphine sulphate

Drug

drug dose as required by patient taken to treat up to four epsiodes of BTCP per day

Other names: IRMS

Primary outcomes

  1. Pain Relief

    Time frame: Various time points

Secondary outcomes

  1. Pain Relief at various time points

    Time frame: Various time points

Sponsors and collaborators

Lead sponsor

Archimedes Development Ltd

Industry

Registry information

Official study title

A Multicentre, Double-Blind, Double-Dummy, Two-Phase Crossover Study of Fentanyl Citrate Nasal Spray Compared to Immediate Release Morphine Sulphate in the Treatment of BTCP in Subjects Taking Regular Opioid Therapy

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Jan 10, 2008
Registry last updated
Jan 22, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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