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Nasal Fentanyl for Chronic Cancer Pain (NFCP-2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01906073
Recruitment Status : Recruiting
First Posted : July 23, 2013
Last Update Posted : January 27, 2020
Sponsor:
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
Information provided by (Responsible Party):
Norwegian University of Science and Technology

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.


Condition or disease Intervention/treatment Phase
Cancer Pain Drug: intranasal fentanyl spray Drug: slow release morphine Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 2017
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : December 2020


Arm Intervention/treatment
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.
Drug: intranasal fentanyl spray
Other Name: Instanyl

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.
Drug: slow release morphine
Other Name: Morphine sulphate pentahydrate




Primary Outcome Measures :
  1. the difference in patient reported satisfaction between the two treatment sessions [ Time Frame: 13 days ]
    measured by the Treatment Satisfaction Questionnaire for Medication (TSQM)


Secondary Outcome Measures :
  1. 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 ]
    5 point Likert scale

  2. Overall rating of average pain control in the two treatment phases [ Time Frame: 26 days ]
    measured by an 11- point numeric rating scale

  3. Overall rating of average side effects in the two treatment phase [ Time Frame: 26 days ]
    measured by an 11-point numeric rate scales



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01906073


Contacts
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Contact: Morten Thronæs, MD morten.thrones@ntnu.no
Contact: Ola Dale, MD prof ola.dale@ntnu.no

Locations
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Australia
Flinders University Recruiting
Flinders, Australia
Contact: David Currow, MD PhD         
Germany
Universitätsklinikum Bonn Recruiting
Bonn, Germany
Contact: Lukas Radbruch, MD PhD         
Italy
Fondazione IRCCS Istituto Nazionale dei Tumori Recruiting
Milan, Italy
Contact: Augusto Caraceni, MD PhD         
Netherlands
Maastricht University Medical Centre Recruiting
Maastricht, Netherlands
Contact: Annemie Schols, MD PhD         
Norway
St Olavs Hospital Recruiting
Trondheim, Norway
Contact: Morten Thronæs, MD       morten.thrones@ntnu.no   
Contact: Ola Dale, MD prof       ola.dale@ntnu.no   
Spain
L'Hospitalet de Llobregat Recruiting
Barcelona, Spain
Contact: Josep Porta Sales, MD PhD         
Switzerland
Kantonsspital St. Gallen Recruiting
St Gallen, Switzerland
Contact: Florian Strasser, MD PhD         
Sponsors and Collaborators
Norwegian University of Science and Technology
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
Investigators
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Study Director: Stein Kaasa, MD prof Norwegian University of Science and Technology
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Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01906073    
Other Study ID Numbers: NFCP-2
First Posted: July 23, 2013    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Norwegian University of Science and Technology:
fentanyl
administration, intranasal
morphine
patient satisfaction
patient preference
Additional relevant MeSH terms:
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Cancer Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Fentanyl
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics