Chronic PainPhase 1/2NFCP1-2010NCT01248611
Nasal Fentanyl for Patient Controlled Treatment of Pain in Cancer
A Phase 1/2 study testing fentanyl in people with Chronic Pain and Cancer, run by St. Olavs Hospital at 1 site in Norway.
Trial summary
Traditionally cancer pain is treated with long acting opioids such as morphine around the clock. However, there is no evidence that all patients have a stable pain requiring around the clock medication. So far opioids for self-administration with a rapid onset of action have not been available. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Cancer
- What is being tested?
- fentanyl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2011to Sep 2011
- Phase
- Phase 1/2
- 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
- Cancer patients with metastatic disease
- Adult (older than 18 years)
- Life expectancy of > 3 months
- Cancer-related pain > 3 on an 11 point Numerical Rating Scale (NRS)
- In the need of opioids (step II or III)
- Able to use nasal drugs.
- Women of child bearing potential using adequate contraception
- Informed consent given according to applicable requirements before any trial-related activities. Trial-related activities are any procedure that would not have been performed during the routine management of the patient
Who cannot join
- History of substance abuse
- Cognitive impairment which makes the patient unable to complete questionnaires or not able to comply with the study procedures
- Treated with MAO inhibitor within the last 14 days
- Known hypersensitivity to study drug or specific contraindications to the study drug
- Nasopharyngeal device such as gastric tube
- Concomitant participation in any other trials dealing with pain with an investigational drug or device apart from cancer treatment within 14 days prior to inclusion in this trial
Show all 10Show fewer
- Pathological conditions of the nasal cavity as contraindication to nasal fentanyl
- Sleep apnoea syndrome
- Pregnant or breastfeeding women
- Psychiatric disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nasal Fentanyl for Patient Controlled Treatment of Pain in Cancer An Open Label Prospective Phase I b Study
Traditionally cancer pain is treated with long acting opioids such as morphine around the clock. However, there is no evidence that all patients have a stable pain requiring around the clock medication. So far opioids for self-administration with a rapid onset of action have not been available. Recently a nasal formulation of fentanyl (an opioid similar to morphine) was released in Europe for treatment of breakthrough pain, i.e. an unpredictable pain with short duration that breaks through the otherwise stable pain controlled with the around the clock medication. The basic idea is that this formulation may open for patient controlled analgesia of chronic cancer pain, due to the ultra rapid onset of action of nasally delivered fentanyl. This means that the patient only takes medication when in pain. This single center feasibility / safety study is the first part of a study to investigate this alternative cancer pain treatment approach.
- Conditions
- Chronic Pain, Cancer
- Being tested
- fentanyl
- Keywords
- pain, adverse effects, safety, feasibility
- Medical subject headings
- Chronic Pain, Neoplasms, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fentanylDrug
Also called Instanyl (nNcomed Pharma)
nasally, dose titrated to effect
| Study group | Role | What they receive |
|---|---|---|
| fentanyl | Experimental | cancer patients with pain Receives: Drug: fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
sedation/drowsiness
scores on a 0-10 numerical rating scale; 0=none / 10=intolerable
Measured: 10 days
nausea and vomiting
nausea scores on a 0-10 numerical rating scale; 0=none / 10=intolerable vomiting yes/no
Measured: 10 days
Secondary outcomes (1)
pain intensity
scores on a 0-10 numerical rating scale; 0=none / 10=intolerable
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2010 (estimated)
- Study startJan 2011
- Primary completionMay 2011
- Study completionSep 2011
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 Chronic PainStudies of the same condition, open and under way.
- More trials run by St. Olavs HospitalThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stein Kaasa, MD. PhD, Principal investigator, St.Olav's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01248611
- Sponsor's protocol ID
- NFCP1-2010
- Acronym
- NFCP1-2010
- Status last verified
- May 2014
- First submitted
- 18 Nov 2010
- Last updated
- 12 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Thronaes M, Kaasa S, Dale O. A pilot study of nasal fentanyl for patient controlled treatment of cancer pain. J Opioid Manag. 2014 Jan-Feb;10(1):21-8. doi: 10.5055/jom.2014.0188.
PubMed 24604566
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nasal Fentanyl for Patient Controlled Treatment of Pain in Cancer An Open Label Prospective Phase I b Study
- ClinicalTrials.gov ID
- NCT01248611
- Acronym / sponsor ID
- NFCP1-2010 / NFCP1-2010
- Conditions
- Chronic Pain, Cancer
- Keywords
- pain, adverse effects, safety, feasibility
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- May 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 25 Nov 2010 (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.
Traditionally cancer pain is treated with long acting opioids such as morphine around the clock. However, there is no evidence that all patients have a stable pain requiring around the clock medication. So far opioids for self-administration with a rapid onset of action have not been available. Recently a nasal formulation of fentanyl (an opioid similar to morphine) was released in Europe for treatment of breakthrough pain, i.e. an unpredictable pain with short duration that breaks through the otherwise stable pain controlled with the around the clock medication. The basic idea is that this formulation may open for patient controlled analgesia of chronic cancer pain, due to the ultra rapid onset of action of nasally delivered fentanyl. This means that the patient only takes medication when in pain. This single center feasibility / safety study is the first part of a study to investigate this alternative cancer pain treatment approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| fentanyl | Experimental | Drug: fentanylcancer patients with pain |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Cancer patients with metastatic disease
- Adult (older than 18 years)
- Life expectancy of > 3 months
- Cancer-related pain > 3 on an 11 point Numerical Rating Scale (NRS)
- In the need of opioids (step II or III)
Key exclusion criteria (10 listed)
- History of substance abuse
- Cognitive impairment which makes the patient unable to complete questionnaires or not able to comply with the study procedures
- Treated with MAO inhibitor within the last 14 days
- Known hypersensitivity to study drug or specific contraindications to the study drug
- Nasopharyngeal device such as gastric tube
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 |
|---|---|---|
| fentanylAlso: Instanyl (nNcomed Pharma)nasally, dose titrated to effect | Drug | fentanyl |
Primary outcome
sedation/drowsiness
Time frame: 10 days
scores on a 0-10 numerical rating scale; 0=none / 10=intolerable
nausea and vomiting
Time frame: 10 days
nausea scores on a 0-10 numerical rating scale; 0=none / 10=intolerable vomiting yes/no
1 secondary outcome
pain intensity
Time frame: 10 days
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 12 May 2014.
- Results publication: PubMed 24604566Thronaes M, Kaasa S, Dale O. A pilot study of nasal fentanyl for patient controlled treatment of cancer pain. J Opioid Manag. 2014 Jan-Feb;10(1):21-8. doi: 10.5055/jom.2014.0188.
Related trials for Chronic Pain
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
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.
Stein Kaasa, MD. PhD principal investigator
St.Olav's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing fentanyl in people with Chronic Pain and Cancer, run by St. Olavs Hospital at 1 site in Norway.
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 8 inclusion and 10 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 12 May 2014. 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 Norway. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
sedation/drowsiness (time frame: 10 days). The study lists 2 primary outcomes in all. 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 NCT01248611, 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 12 May 2014.