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Trial record 3 of 5 for:    FCNS

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

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: NCT00589823
Recruitment Status : Completed
First Posted : January 10, 2008
Last Update Posted : January 22, 2010
Information provided by:
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 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.

Condition or disease Intervention/treatment Phase
Cancers, Pain Drug: Fentanyl citrate Drug: Immediate release morphine sulphate 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 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 135 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official 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
Study Start Date : June 2007
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 1
Immediate Release Morphine sulphate capsules taken at start of relevant BTCP episode. Each episode treated with either this medication OR the experimental comparator.
Drug: Fentanyl citrate
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

Experimental: 2
Nasalfent spray taken at start of relevant BTCP episode. Each episode to be treated with either this medication OR the active comparator (IRMS)
Drug: Immediate release morphine sulphate
drug dose as required by patient taken to treat up to four epsiodes of BTCP per day
Other Name: IRMS

Primary Outcome Measures :
  1. Pain Relief [ Time Frame: Various time points ]

Secondary Outcome Measures :
  1. Pain Relief at various time points [ Time Frame: Various time points ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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): NCT00589823

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United Kingdom
Prof Fallon
Edinburgh, United Kingdom
Sponsors and Collaborators
Archimedes Development Ltd
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Principal Investigator: Marie Fallon Western General Hospital, Edinburgh Cancer Centre
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Responsible Party: Mark Watling, Group Medical Director, Archimedes Development Ltd Identifier: NCT00589823    
Other Study ID Numbers: CPO44/06/FCNS
First Posted: January 10, 2008    Key Record Dates
Last Update Posted: January 22, 2010
Last Verified: January 2010
Keywords provided by Archimedes Development Ltd:
Additional relevant MeSH terms:
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Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General