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Withdrawn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
About this trial
This is an interventional treatment trial for Cancer Pain
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
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
NCT ID
NCT05053308
First Posted
August 30, 2021
Last Updated
August 3, 2023
Sponsor
Seoul National University
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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