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A Multicenter, Placebo-Controlled, Double-Blind, Two-Phase Crossover Study of Nasalfent (Fentanyl Citrate Nasal Spray) in the Treatment of Breakthrough Cancer Pain (BTCP) in Subjects Taking Regular Opioid Therapy


Phase 3
18 Years
N/A
Not Enrolling
Both
Cancer Pain

Thank you

Trial Information

A Multicenter, Placebo-Controlled, Double-Blind, Two-Phase Crossover Study of Nasalfent (Fentanyl Citrate Nasal Spray) in the Treatment of Breakthrough Cancer Pain (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 most 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
Placebo. The safety of the two treatments groups (Nasalfent, Placebo) 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:

Summed pain intensity difference at 30 min

Outcome Time Frame:

30 min after dosing

Safety Issue:

No

Principal Investigator

Russell K Portenoy, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beth Israel Medical Center

Authority:

United States: Food and Drug Administration

Study ID:

CPO43/06/FCNS

NCT ID:

NCT00459277

Start Date:

December 2006

Completion Date:

August 2008

Related Keywords:

  • Cancer Pain
  • Pain
  • Cancer

Name

Location

Beth Israel Medical CenterNew York, New York  10003