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Efficacy & Safety Study of Nasalfent (Fentanyl Citrate Nasal Spray) for Treatment of Breakthrough Cancer Pain in Patients Taking Regular Opioids

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ClinicalTrials.gov Identifier: NCT00459277
Recruitment Status : Completed
First Posted : April 11, 2007
Last Update Posted : January 25, 2012
Sponsor:
Information provided by (Responsible Party):
Archimedes Development Ltd

Tracking Information
First Submitted Date  ICMJE April 10, 2007
First Posted Date  ICMJE April 11, 2007
Last Update Posted Date January 25, 2012
Study Start Date  ICMJE December 2006
Actual Primary Completion Date July 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 20, 2012)
Summed pain intensity difference at 30 min [ Time Frame: 30 min after dosing ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 10, 2007)
Pain Relief
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 20, 2012)
SPID, Pain intensity, Pain intensity difference, Pain relief and Total pain relief [ Time Frame: Various timepoints ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2007)
Pain Relief at various time points
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy & Safety Study of Nasalfent (Fentanyl Citrate Nasal Spray) for Treatment of Breakthrough Cancer Pain in Patients Taking Regular Opioids
Official Title  ICMJE 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
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 pain killer 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 in the treatment of breakthrough cancer pain.
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 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Cancer Pain
Intervention  ICMJE Drug: Fentanyl (Nasalfent, Fentanyl Citrate Nasal Spray)
Study Arms  ICMJE
  • Experimental: Nasalfent, Fentanyl Citrate Nasal Spray
    Intervention: Drug: Fentanyl (Nasalfent, Fentanyl Citrate Nasal Spray)
  • Placebo Comparator: Placebo Spray
    Intervention: Drug: Fentanyl (Nasalfent, Fentanyl Citrate Nasal Spray)
Publications * Taylor D, Galan V, Weinstein SM, Reyes E, Pupo-Araya AR, Rauck R; Fentanyl Pectin Nasal Spray 043 Study Group. Fentanyl pectin nasal spray in breakthrough cancer pain. J Support Oncol. 2010 Jul-Aug;8(4):184-90. Erratum in: J Support Oncol. 2010 Sep-Oct;8(5):201.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 20, 2012)
73
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE August 2008
Actual Primary Completion Date July 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00459277
Other Study ID Numbers  ICMJE CPO43/06/FCNS
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Archimedes Development Ltd
Study Sponsor  ICMJE Archimedes Development Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Russell K Portenoy, MD Beth Israel Medical Center
PRS Account Archimedes Development Ltd
Verification Date January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP