Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE3
INTERVENTIONAL
2017-01-31
2020-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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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.
intranasal fentanyl spray
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.
slow release morphine
Interventions
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intranasal fentanyl spray
slow release morphine
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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St. Olavs Hospital
OTHER
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
OTHER
L'Hospitalet de Llobregat
OTHER
University Hospital, Bonn
OTHER
Cantonal Hospital of St. Gallen
OTHER
Maastricht University Medical Center
OTHER
Flinders University
OTHER
Norwegian University of Science and Technology
OTHER
Responsible Party
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Principal Investigators
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Stein Kaasa, MD prof
Role: STUDY_DIRECTOR
Norwegian University of Science and Technology
Countries
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Other Identifiers
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NFCP-2
Identifier Type: -
Identifier Source: org_study_id