CancerPhase 3NFCP-2NCT01906073
Nasal Fentanyl for Chronic Cancer Pain
A Phase 3 study testing intranasal fentanyl spray and slow release morphine in people with Cancer and Pain, run by Norwegian University of Science and Technology.
Trial summary
Today, patients with cancer pain in need of opioids for moderate to severe pain get long-acting morphine twice a day and morphine tablets taken on demand in addition. This procedure might be based on the assumption that cancer pain is persistent, although the evidence to support whether this assumption applies to all… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- intranasal fentanyl spray and slow release morphine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Dec 2020
- 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
- Cancer disease
- Adult (older than 18 years)
- Cancer-related pain > 4 on an 11 point Numerical Rating Scale (NRS)
- In the need of opioids (step II or III)
- Able to use nasal drugs.
- Life expectancy of > 6 months
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- Karnofsky status > = 60
- Women of child bearing potential must use adequate contraception
- Informed consent given according to applicable requirements before any trial-related activities.
Who cannot join
- Use of opioids for moderate and severe pain
- History of substance abuse.*
- Pathological conditions of the nasal cavity as contraindication to nasal fentanyl
- Renal- or liver- failure, defined as creatinin > 150 and alanine-amino transferase (ALAT) > x 1.5 reference value
- Sleep apnoea syndrome, severe chronic obstructive lung disease or illnesses leading to severe respiratory depression.
- Psychiatric disease
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- Neurological disease giving dizziness or sedation
- Cognitive impairment which makes the patient unable to complete questionnaires or not able to comply with the study procedures.
- Previous or ongoing facial radiotherapy
- Recurrent nose bleeding
- Known hypersensitivity to the active substances or excipients of the study drugs
- Pregnant or breastfeeding women
- Treated with monoamine oxidase (MAO) inhibitor within the last 14 days
About this study
Official title: An Open Label, Cross-over, Randomized Controlled Multicenter Phase III Study Comparing Standard Oral SR-morphine by the Clock Medications With Self-controlled Nasal Fentanyl for Chronic Cancer Pain Requiring Opioids
Today, patients with cancer pain in need of opioids for moderate to severe pain get long-acting morphine twice a day and morphine tablets taken on demand in addition. This procedure might be based on the assumption that cancer pain is persistent, although the evidence to support whether this assumption applies to all cancer patients is lacking. Some cancer patients might not need a fixed dose of long-acting morphine.
Because of rapid pain relief, the new fentanyl drugs open for the possibility to take an opioid on demand when pain occurs.
Read more
A pilot study where 10 patients with cancer pain were treated with a rapid-acting fentanyl nasal spray taken on demand, showed that this treatment was apparently feasible and safe for these patients.
This approach is studied further in NFCP-II. The participants will be treated with rapid-acting fentanyl nasal spray and long-acting morphine in a crossover study. The primary outcome will be patient satisfaction.
The study will consist of a test dose of nasal fentanyl, a dose-finding phase and a treatment phase with either nasal fentanyl taken on demand or slow-released morphine taken twice a day. After 10 days of treatment there is a crossover and the opposite drug is used for the same participant. Morphine tablets can be taken on demand in all phases of the study.
The participants will meet the investigator at inclusion, at the crossover and at the end of treatment. During the study, a diary is filled in by the participants every morning. Questions about pain and side effects are answered. Satisfaction is measured at the crossover and at end of treatment while preference is measured at the end of treatment.
- Being tested
- intranasal fentanyl spray, slow release morphine
- Keywords
- fentanyl, administration, intranasal, morphine, patient satisfaction, patient preference
- Medical subject headings
- Neoplasms, Pain, Patient Satisfaction, Patient Preference
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intranasal fentanyl sprayDrug
Also called Instanyl
slow release morphineDrug
Also called Morphine sulphate pentahydrate
| Study group | Role | What they receive |
|---|---|---|
| intranasal fentanyl spray | Experimental | Fentanyl for nasal administration (NF), is supplied as sprays containing a phosphate buffered solution of fentanyl citrate. NF is available in three strengths: 0.5 mg/ml, 1 mg/ml and 2 mg/ml in multiple-dose sprays. The corresponding doses are 50, 100 and 200 µg/puff. NF is applied as one puff in one nostril. One puff defines and equals one dose. Applying a puff to each nostril the upper dose can be increased to 400 µg. The doses used in this study are 50, 100, 200 ad 400µg. Fentanyl may be administered for up to 6 pain episodes/ 24 hours. For each pain episode, a dose of NF is self-administrated in one nostril. If pain relief is not achieved, another dose of NF could be administered in the opposite nostril after 15 minutes. Receives: Drug: intranasal fentanyl spray |
| slow release morphine | Active comparator | The active substance is released gradually during its transit through the gastrointestinal tract. Slow release (SR) morphine is available in 5, 10, 30, 60, 100 and 200 mg. SR morphine is administered twice a day, usually every twelfth hour. Receives: Drug: slow release morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
the difference in patient reported satisfaction between the two treatment sessions
measured by the Treatment Satisfaction Questionnaire for Medication (TSQM)
Measured: 13 days
Secondary outcomes (3)
Patient preference (overall; including pain relief, tolerance to adverse effects and convenience) of treatments after finishing the second part of the clinical study
5 point Likert scale
Measured: 26 days
Overall rating of average pain control in the two treatment phases
measured by an 11- point numeric rating scale
Measured: 26 days
Overall rating of average side effects in the two treatment phase
measured by an 11-point numeric rate scales
Measured: 26 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2013 (estimated)
- Study startJan 2017
- Primary completionDec 2020
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, L'Hospitalet de Llobregat, University Hospital, Bonn, Cantonal Hospital of St. Gallen, Maastricht University Medical Center, Flinders University
- Responsible party
- Sponsor
- Investigators
- Stein Kaasa, MD prof, Study director, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01906073
- Sponsor's protocol ID
- NFCP-2
- Acronym
- NFCP-2
- Status last verified
- Dec 2020
- First submitted
- 19 Jul 2013
- Last updated
- 10 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Cross-over, Randomized Controlled Multicenter Phase III Study Comparing Standard Oral SR-morphine by the Clock Medications With Self-controlled Nasal Fentanyl for Chronic Cancer Pain Requiring Opioids
- ClinicalTrials.gov ID
- NCT01906073
- Acronym / sponsor ID
- NFCP-2 / NFCP-2
- Keywords
- fentanyl, administration, intranasal, morphine, patient satisfaction, patient preference
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, L'Hospitalet de Llobregat, University Hospital, Bonn, Cantonal Hospital of St. Gallen, Maastricht University Medical Center, Flinders University
- Study start
- Jan 2017 (actual)
- Primary completion
- Dec 2020 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 23 Jul 2013 (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.
Today, patients with cancer pain in need of opioids for moderate to severe pain get long-acting morphine twice a day and morphine tablets taken on demand in addition. This procedure might be based on the assumption that cancer pain is persistent, although the evidence to support whether this assumption applies to all cancer patients is lacking. Some cancer patients might not need a fixed dose of long-acting morphine.
Because of rapid pain relief, the new fentanyl drugs open for the possibility to take an opioid on demand when pain occurs.
A pilot study where 10 patients with cancer pain were treated with a rapid-acting fentanyl nasal spray taken on demand, showed that this treatment was apparently feasible and safe for these patients.
This approach is studied further in NFCP-II. The participants will be treated with rapid-acting fentanyl nasal spray and long-acting morphine in a crossover study. The primary outcome will be patient satisfaction.
The study will consist of a test dose of nasal fentanyl, a dose-finding phase and a treatment phase with either nasal fentanyl taken on demand or slow-released morphine taken twice a day. After 10 days of treatment there is a crossover and the opposite drug is used for the same participant. Morphine tablets can be taken on demand in all phases of the study.
The participants will meet the investigator at inclusion, at the crossover and at the end of treatment. During the study, a diary is filled in by the participants every morning. Questions about pain and side effects are answered. Satisfaction is measured at the crossover and at end of treatment while preference is measured at the end of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intranasal fentanyl spray | Experimental | Drug: intranasal fentanyl sprayFentanyl for nasal administration (NF), is supplied as sprays containing a phosphate buffered solution of fentanyl citrate. NF is available in three strengths: 0.5 mg/ml, 1 mg/ml and 2 mg/ml in multiple-dose sprays. The corresponding doses are 50, 100 and 200 µg/puff. NF is applied as one puff in one nostril. One puff defines and equals one dose. Applying a puff to each nostril the upper dose can be increased to 400 µg. The doses used in this study are 50, 100, 200 ad 400µg. Fentanyl may be administered for up to 6 pain episodes/ 24 hours. For each pain episode, a dose of NF is self-administrated in one nostril. If pain relief is not achieved, another dose of NF could be administered in the opposite nostril after 15 minutes. |
| slow release morphine | Active comparator | Drug: slow release morphineThe active substance is released gradually during its transit through the gastrointestinal tract. Slow release (SR) morphine is available in 5, 10, 30, 60, 100 and 200 mg. SR morphine is administered twice a day, usually every twelfth hour. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Cancer disease
- Adult (older than 18 years)
- Cancer-related pain > 4 on an 11 point Numerical Rating Scale (NRS)
- In the need of opioids (step II or III)
- Able to use nasal drugs.
Key exclusion criteria (13 listed)
- Use of opioids for moderate and severe pain
- History of substance abuse.*
- Pathological conditions of the nasal cavity as contraindication to nasal fentanyl
- Renal- or liver- failure, defined as creatinin > 150 and alanine-amino transferase (ALAT) > x 1.5 reference value
- Sleep apnoea syndrome, severe chronic obstructive lung disease or illnesses leading to severe respiratory depression.
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 |
|---|---|---|
| intranasal fentanyl sprayAlso: Instanyl | Drug | intranasal fentanyl spray |
| slow release morphineAlso: Morphine sulphate pentahydrate | Drug | slow release morphine |
Primary outcome
the difference in patient reported satisfaction between the two treatment sessions
Time frame: 13 days
measured by the Treatment Satisfaction Questionnaire for Medication (TSQM)
3 secondary outcomes
Patient preference (overall; including pain relief, tolerance to adverse effects and convenience) of treatments after finishing the second part of the clinical study
Time frame: 26 days
Overall rating of average pain control in the two treatment phases
Time frame: 26 days
Overall rating of average side effects in the two treatment phase
Time frame: 26 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2020.
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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.
Stein Kaasa, MD prof study director
Norwegian University of Science and Technology
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing intranasal fentanyl spray and slow release morphine in people with Cancer and Pain, run by Norwegian University of Science and Technology.
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 9 inclusion and 13 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: withdrawn, as of the sponsor's last update on 10 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
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 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 was withdrawn before enrolling participants, so there are no results.
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?
the difference in patient reported satisfaction between the two treatment sessions (time frame: 13 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Dec 2020.