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Proportional Dose of Sublingual Fentanyl Tablet Based on Daily Opioid Requirement

Primary Purpose

Cancer Pain, Breakthrough Pain

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Intravenous Infusion
Sublingual Tablet
Sponsored by
Seoul National University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cancer Pain

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 19-80
  • Cancer pain
  • Admission for the control of cancer pain or consultation for the treatment of cancer pain
  • Stable vital sign
  • ECOG status ≤ 3 for more than 1 or 2 months
  • Opioid-tolerant state
  • No history of using sublingual fentanyl

Exclusion Criteria:

  • Noncancer pain
  • Opioid naive
  • baseline NRS pain score> 4
  • Current using sublingual fentanyl
  • Difficult to assess cancer pain
  • no evidence of disease(cancer)
  • Planned surgical resection of cancer
  • Allergy to fentanyl
  • Severe renal and/or liver function
  • Severe respiratory depression or uncontrolled COPD

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    IV PCA (proportional dosage)

    SL-FTN (equivalent dose for PCA bolus)

    Arm Description

    Breakthrough pain control by bolus based IV patient-controlled anagesia Fentanyl bolus = MME * 15%

    Breakthrough pain control by sublingual fentanyl Fentanyl 100mcg/200mcg/300mcg according to the around-the-clock opioid requirement.

    Outcomes

    Primary Outcome Measures

    Change in 11-point scale NRS pain score
    Change in pain score compared to baseline Score '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable"

    Secondary Outcome Measures

    Change in 11-point scale NRS pain score
    Change in pain score compared to baseline Score '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable"
    sum of pain intensity difference(SPID)
    sum of pain intensity change compared to baseline difference
    number of additional doses
    number of additional doses fentanyl bolus or subligual
    Pain interference
    Pain interference using BPI-SF
    Insomnia
    The severity of insomnia using ISI
    Depression
    The severity of depression using Beck Depression Inventory(BDI) 1-10: These ups and downs are considered normal 11-16: Mild mood disturbance 17-20: Borderline clinical depression 21-30: Moderate depression 31-40: Severe depression over 40: Extreme depression
    Satisfaction scale
    Satisfaction check using 5 Likert-scale (1) Very dissatisfied; (2) Not satisfied; (3) Neutral; (4) Satisfied; (5) Very satidfied

    Full Information

    First Posted
    August 30, 2021
    Last Updated
    August 3, 2023
    Sponsor
    Seoul National University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05053308
    Brief Title
    Proportional Dose of Sublingual Fentanyl Tablet Based on Daily Opioid Requirement
    Official Title
    Proportional Dose of Sublingual Fentanyl Tablet Based on Daily Opioid Requirement Versus Intravenous PCA for Breakthrough Cancer Pain: A Prospective, Randomized, Open Label, Non Inferiority Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    The supply of IP is disrupted
    Study Start Date
    December 1, 2022 (Anticipated)
    Primary Completion Date
    May 31, 2023 (Anticipated)
    Study Completion Date
    December 31, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Seoul National University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Proportional dose of sublingual fentanyl tablet (Narco®) based on daily opioid requirement versus intravenous PCA for breakthrough cancer pain: A prospective, randomized, open-label, noninferiority trial.
    Detailed Description
    Based on the previous around-the-clock analgesic demand compared to IV PCA in cancer pain patients to prepare the basis for the administration of fentanyl sublingual tablets with an initial dose.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cancer Pain, Breakthrough Pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    IV PCA (proportional dosage)
    Arm Type
    Active Comparator
    Arm Description
    Breakthrough pain control by bolus based IV patient-controlled anagesia Fentanyl bolus = MME * 15%
    Arm Title
    SL-FTN (equivalent dose for PCA bolus)
    Arm Type
    Experimental
    Arm Description
    Breakthrough pain control by sublingual fentanyl Fentanyl 100mcg/200mcg/300mcg according to the around-the-clock opioid requirement.
    Intervention Type
    Drug
    Intervention Name(s)
    Intravenous Infusion
    Other Intervention Name(s)
    PCA
    Intervention Description
    IV PCA(fentanyl) Fentanyl bolus = MME * 15%
    Intervention Type
    Drug
    Intervention Name(s)
    Sublingual Tablet
    Other Intervention Name(s)
    sublingual
    Intervention Description
    subligual fentanyl(Narco®) Fentanyl 100mcg/200mcg/300mcg according to the around-the-clock opioid requirement.
    Primary Outcome Measure Information:
    Title
    Change in 11-point scale NRS pain score
    Description
    Change in pain score compared to baseline Score '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable"
    Time Frame
    30 minutes after administration
    Secondary Outcome Measure Information:
    Title
    Change in 11-point scale NRS pain score
    Description
    Change in pain score compared to baseline Score '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable"
    Time Frame
    15, 45, 60 minutes after administration
    Title
    sum of pain intensity difference(SPID)
    Description
    sum of pain intensity change compared to baseline difference
    Time Frame
    60 minutes after administration
    Title
    number of additional doses
    Description
    number of additional doses fentanyl bolus or subligual
    Time Frame
    immediately after the intervention
    Title
    Pain interference
    Description
    Pain interference using BPI-SF
    Time Frame
    immediately after the intervention
    Title
    Insomnia
    Description
    The severity of insomnia using ISI
    Time Frame
    immediately after the intervention
    Title
    Depression
    Description
    The severity of depression using Beck Depression Inventory(BDI) 1-10: These ups and downs are considered normal 11-16: Mild mood disturbance 17-20: Borderline clinical depression 21-30: Moderate depression 31-40: Severe depression over 40: Extreme depression
    Time Frame
    immediately after the intervention
    Title
    Satisfaction scale
    Description
    Satisfaction check using 5 Likert-scale (1) Very dissatisfied; (2) Not satisfied; (3) Neutral; (4) Satisfied; (5) Very satidfied
    Time Frame
    immediately after the intervention

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    19 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age 19-80 Cancer pain Admission for the control of cancer pain or consultation for the treatment of cancer pain Stable vital sign ECOG status ≤ 3 for more than 1 or 2 months Opioid-tolerant state No history of using sublingual fentanyl Exclusion Criteria: Noncancer pain Opioid naive baseline NRS pain score> 4 Current using sublingual fentanyl Difficult to assess cancer pain no evidence of disease(cancer) Planned surgical resection of cancer Allergy to fentanyl Severe renal and/or liver function Severe respiratory depression or uncontrolled COPD
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jee Youn Moon, MD, PhD
    Organizational Affiliation
    Seoul National University Hospital
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    Proportional Dose of Sublingual Fentanyl Tablet Based on Daily Opioid Requirement

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