Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01906073




Registration number
NCT01906073
Ethics application status
Date submitted
19/07/2013
Date registered
23/07/2013
Date last updated
10/12/2020

Titles & IDs
Public title
Nasal Fentanyl for Chronic Cancer Pain
Scientific 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
Secondary ID [1] 0 0
NFCP-2
Universal Trial Number (UTN)
Trial acronym
NFCP-2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 0 0
Pain 0 0
Condition category
Condition code
Cancer 0 0 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - intranasal fentanyl spray
Treatment: Drugs - slow release morphine

Experimental: intranasal fentanyl spray - 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.

Active Comparator: slow release morphine - 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.


Treatment: Drugs: intranasal fentanyl spray


Treatment: Drugs: slow release morphine
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
the difference in patient reported satisfaction between the two treatment sessions
Timepoint [1] 0 0
13 days
Secondary outcome [1] 0 0
Patient preference (overall; including pain relief, tolerance to adverse effects and convenience) of treatments after finishing the second part of the clinical study
Timepoint [1] 0 0
26 days
Secondary outcome [2] 0 0
Overall rating of average pain control in the two treatment phases
Timepoint [2] 0 0
26 days
Secondary outcome [3] 0 0
Overall rating of average side effects in the two treatment phase
Timepoint [3] 0 0
26 days

Eligibility
Key inclusion criteria
1. Cancer disease

2. Adult (older than 18 years)

3. Cancer-related pain > 4 on an 11 point Numerical Rating Scale (NRS)

4. In the need of opioids (step II or III)

5. Able to use nasal drugs.

6. Life expectancy of > 6 months

7. Karnofsky status > = 60

8. Women of child bearing potential must use adequate contraception

9. Informed consent given according to applicable requirements before any trial-related
activities.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Use of opioids for moderate and severe pain

2. History of substance abuse.*

3. Pathological conditions of the nasal cavity as contraindication to nasal fentanyl

4. Renal- or liver- failure, defined as creatinin > 150 and alanine-amino transferase
(ALAT) > x 1.5 reference value

5. Sleep apnoea syndrome, severe chronic obstructive lung disease or illnesses leading to
severe respiratory depression.

6. Psychiatric disease

7. Neurological disease giving dizziness or sedation

8. Cognitive impairment which makes the patient unable to complete questionnaires or not
able to comply with the study procedures.

9. Previous or ongoing facial radiotherapy

10. Recurrent nose bleeding

11. Known hypersensitivity to the active substances or excipients of the study drugs

12. Pregnant or breastfeeding women

13. Treated with monoamine oxidase (MAO) inhibitor within the last 14 days

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2020
Sample size
Target
Accrual to date
Final
0
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Primary sponsor type
Other
Name
Norwegian University of Science and Technology
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
St. Olavs Hospital
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
L'Hospitalet de Llobregat
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
University Hospital, Bonn
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Cantonal Hospital of St. Gallen
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
Maastricht University Medical Center
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Other
Name [7] 0 0
Flinders University
Address [7] 0 0
Country [7] 0 0

Ethics approval
Ethics application status

Summary
Brief 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 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01906073
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Stein Kaasa, MD prof
Address 0 0
Norwegian University of Science and Technology
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01906073