Efficacy and Safety Study of Nasalfent for Treatment of Breakthrough Cancer Pain in Patients Taking Regular Opioids
Information source: Archimedes Development Ltd
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cancer Pain
Intervention: Fentanyl (Drug); Immediate release morphine sulphate (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Archimedes Development Ltd Official(s) and/or principal investigator(s):
Marie Fallon, Principal Investigator, Affiliation: Western General Hospital, Edinburgh Cancer Centre
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 compated to Immediate
Release Morphine Sulphate in the treatment of breakthrough cancer pain.
Clinical Details
Official title: A Multicentre, Double-Blind, Double-Dummy, Two-Phase Crossover Study of Nasalfent (Fentanyl Citrate Nasal Spray) Compared to Immediate Release Morphine Sulphate Tablets in the Treatment of Breakthrough Cancer Pain (BTCP) in Subjects Taking Regular Opioid Therapy
Study design: Supportive Care, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Crossover Assignment, Safety/Efficacy Study
Primary outcome: Pain Relief
Secondary outcome: Pain Relief at various time points
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 groups will also be
examined.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Prof Fallon, Edinburgh, United Kingdom; Recruiting
Marie Fallon, Phone: 44 131 7773518, Email: marie.fallon@ed.ac.uk
Additional Information
Starting date: June 2007
Ending date: February 2009
Last updated: January 12, 2009
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