Cancer PainPhase 3NCT00459277
Efficacy & Safety Study of Nasalfent (Fentanyl Citrate Nasal Spray) for Treatment of Breakthrough Cancer Pain in Patients Taking Regular Opioids
A Phase 3 study testing Fentanyl (Nasalfent, Fentanyl Citrate Nasal Spray) in people with Cancer Pain, run by Archimedes Development Ltd at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Pain
- What is being tested?
- Fentanyl (Nasalfent, Fentanyl Citrate Nasal Spray)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 73 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2006to Aug 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Intolerance to opioids or fentanyl
- rapidly increasing/uncontrolled pain
- pain that is not cancer related
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Medical Center
New York, New York, 10003
About this study
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
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.
Read the 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.
- Conditions
- Cancer Pain
- Being tested
- Fentanyl (Nasalfent, Fentanyl Citrate Nasal Spray)
- Keywords
- Pain, Cancer
- Medical subject headings
- Cancer Pain, Pain, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fentanyl (Nasalfent, Fentanyl Citrate Nasal Spray)Drug
| Study group | Role | What they receive |
|---|---|---|
| Nasalfent, Fentanyl Citrate Nasal Spray | Experimental | Not described Receives: Drug: Fentanyl (Nasalfent, Fentanyl Citrate Nasal Spray) |
| Placebo Spray | Placebo comparator | Not described Receives: Drug: Fentanyl (Nasalfent, Fentanyl Citrate Nasal Spray) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Summed pain intensity difference at 30 min
Measured: 30 min after dosing
Secondary outcomes (1)
SPID, Pain intensity, Pain intensity difference, Pain relief and Total pain relief
Measured: Various timepoints
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2007 (estimated)
- Study startDec 2006
- Primary completionJul 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancer PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Archimedes Development Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Russell K Portenoy, MD, Principal investigator, Beth Israel Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00459277
- Sponsor's protocol ID
- CPO43/06/FCNS
- Status last verified
- Jan 2010
- First submitted
- 10 Apr 2007
- Last updated
- 25 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 20822038
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00459277
- Acronym / sponsor ID
- CPO43/06/FCNS
- Conditions
- Cancer Pain
- Keywords
- Pain, Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Archimedes Development LtdIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Jul 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 11 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nasalfent, Fentanyl Citrate Nasal Spray | Experimental | Drug: Fentanyl (Nasalfent, Fentanyl Citrate Nasal Spray) |
| Placebo Spray | Placebo comparator | Drug: Fentanyl (Nasalfent, Fentanyl Citrate Nasal Spray) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- Intolerance to opioids or fentanyl
- rapidly increasing/uncontrolled pain
- pain that is not cancer related
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fentanyl (Nasalfent, Fentanyl Citrate Nasal Spray) | Drug | Nasalfent, Fentanyl Citrate Nasal Spray, Placebo Spray |
Primary outcome
Summed pain intensity difference at 30 min
Time frame: 30 min after dosing
1 secondary outcome
SPID, Pain intensity, Pain intensity difference, Pain relief and Total pain relief
Time frame: Various timepoints
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2012.
- Derived from this study: PubMed 20822038Taylor 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Russell K Portenoy, MD principal investigator
Beth Israel Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fentanyl (Nasalfent, Fentanyl Citrate Nasal Spray) in people with Cancer Pain, run by Archimedes Development Ltd at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Summed pain intensity difference at 30 min (time frame: 30 min after dosing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00459277, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2012.