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/study/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
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Successful Tissue Expansion and Exchange to Permanent Breast Implant unless Precluded by a Non-Device Related Event
Timepoint [1] 0 0
6 months
Primary outcome [2] 0 0
the difference in patient reported satisfaction between the two treatment sessions
Timepoint [2] 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
Secondary outcome [4] 0 0
Adverse Events related to the Breast Reconstruction Procedure
Timepoint [4] 0 0
6 months

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)
WA
Recruitment hospital [1] 0 0
Mount Hospital - Subiaco
Recruitment postcode(s) [1] 0 0
6008 - Subiaco

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
Trial website
Trial related presentations / publications
Public notes

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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01906073