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Nasal Fentanyl for Chronic Cancer Pain (NFCP-2)

Primary Purpose

Cancer, Pain

Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
intranasal fentanyl spray
slow release morphine
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer focused on measuring fentanyl, administration, intranasal, morphine, patient satisfaction, patient preference

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    intranasal fentanyl spray

    slow release morphine

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    the difference in patient reported satisfaction between the two treatment sessions
    measured by the Treatment Satisfaction Questionnaire for Medication (TSQM)

    Secondary Outcome Measures

    Patient preference (overall; including pain relief, tolerance to adverse effects and convenience) of treatments after finishing the second part of the clinical study
    5 point Likert scale
    Overall rating of average pain control in the two treatment phases
    measured by an 11- point numeric rating scale
    Overall rating of average side effects in the two treatment phase
    measured by an 11-point numeric rate scales

    Full Information

    First Posted
    July 19, 2013
    Last Updated
    December 8, 2020
    Sponsor
    Norwegian University of Science and Technology
    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
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01906073
    Brief Title
    Nasal Fentanyl for Chronic Cancer Pain
    Acronym
    NFCP-2
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2020
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    January 2017 (Actual)
    Primary Completion Date
    December 2020 (Actual)
    Study Completion Date
    December 2020 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Norwegian University of Science and Technology
    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

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cancer, Pain
    Keywords
    fentanyl, administration, intranasal, morphine, patient satisfaction, patient preference

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    intranasal fentanyl spray
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    slow release morphine
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Drug
    Intervention Name(s)
    intranasal fentanyl spray
    Other Intervention Name(s)
    Instanyl
    Intervention Type
    Drug
    Intervention Name(s)
    slow release morphine
    Other Intervention Name(s)
    Morphine sulphate pentahydrate
    Primary Outcome Measure Information:
    Title
    the difference in patient reported satisfaction between the two treatment sessions
    Description
    measured by the Treatment Satisfaction Questionnaire for Medication (TSQM)
    Time Frame
    13 days
    Secondary Outcome Measure Information:
    Title
    Patient preference (overall; including pain relief, tolerance to adverse effects and convenience) of treatments after finishing the second part of the clinical study
    Description
    5 point Likert scale
    Time Frame
    26 days
    Title
    Overall rating of average pain control in the two treatment phases
    Description
    measured by an 11- point numeric rating scale
    Time Frame
    26 days
    Title
    Overall rating of average side effects in the two treatment phase
    Description
    measured by an 11-point numeric rate scales
    Time Frame
    26 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 Criteria: 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Stein Kaasa, MD prof
    Organizational Affiliation
    Norwegian University of Science and Technology
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Nasal Fentanyl for Chronic Cancer Pain

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