Status:
WITHDRAWN
Nasal Fentanyl for Chronic Cancer Pain
Lead Sponsor:
Norwegian University of Science and Technology
Collaborating Sponsors:
St. Olavs Hospital
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Conditions:
Cancer
Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- Karnofsky status \> = 60
- Women of child bearing potential must use adequate contraception
- Informed consent given according to applicable requirements before any trial-related activities.
Exclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01906073
Start Date
January 1 2017
End Date
December 1 2020
Last Update
December 10 2020
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