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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Cancers, Pain

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Outcome Measure:

Pain Relief

Outcome Time Frame:

Various time points

Safety Issue:

No

Principal Investigator

Marie Fallon

Investigator Role:

Principal Investigator

Investigator Affiliation:

Western General Hospital, Edinburgh Cancer Centre

Authority:

Czech Republic: Ethics Committee

Study ID:

CPO44/06/FCNS

NCT ID:

NCT00589823

Start Date:

June 2007

Completion Date:

March 2009

Related Keywords:

  • Cancers, Pain
  • Pain
  • Cancer
  • Breakthrough

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