Efficacy & Safety Study of Nasalfent (Fentanyl Citrate Nasal Spray) for Treatment of Breakthrough Cancer Pain in Patients Taking Regular Opioids
Primary Purpose
Cancer Pain
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Fentanyl (Nasalfent, Fentanyl Citrate Nasal Spray)
Sponsored by
About this trial
This is an interventional supportive care trial for Cancer Pain focused on measuring Pain, Cancer
Eligibility 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
Sites / Locations
- Beth Israel Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Nasalfent, Fentanyl Citrate Nasal Spray
Placebo Spray
Arm Description
Outcomes
Primary Outcome Measures
Summed pain intensity difference at 30 min
Secondary Outcome Measures
SPID, Pain intensity, Pain intensity difference, Pain relief and Total pain relief
Full Information
NCT ID
NCT00459277
First Posted
April 10, 2007
Last Updated
January 20, 2012
Sponsor
Archimedes Development Ltd
1. Study Identification
Unique Protocol Identification Number
NCT00459277
Brief Title
Efficacy & Safety Study of Nasalfent (Fentanyl Citrate Nasal Spray) for Treatment of Breakthrough Cancer Pain in Patients Taking Regular Opioids
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
August 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Archimedes Development Ltd
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer Pain
Keywords
Pain, Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
73 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nasalfent, Fentanyl Citrate Nasal Spray
Arm Type
Experimental
Arm Title
Placebo Spray
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Fentanyl (Nasalfent, Fentanyl Citrate Nasal Spray)
Primary Outcome Measure Information:
Title
Summed pain intensity difference at 30 min
Time Frame
30 min after dosing
Secondary Outcome Measure Information:
Title
SPID, Pain intensity, Pain intensity difference, Pain relief and Total pain relief
Time Frame
Various timepoints
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Russell K Portenoy, MD
Organizational Affiliation
Beth Israel Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20822038
Citation
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.
Results Reference
derived
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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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