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WithdrawnNCT05053308Updated Aug 7, 2023

Proportional Dose of Sublingual Fentanyl Tablet Based on Daily Opioid Requirement

An interventional study of Intravenous Infusion and Sublingual Tablet in Cancer Pain and Breakthrough Pain, sponsored by Seoul National University. Withdrawn. Open to participants aged 19 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-08-07.

Sponsored by Seoul National University · Not applicable, Interventional, and Treatment

Why this study was withdrawn
The supply of IP is disrupted
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
19 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cancer Pain
  • Breakthrough Pain
03

Who can participate

Ages eligible
19 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Active comparator
    IV PCA (proportional dosage)

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

    Drug: Intravenous Infusion

  • Experimental
    SL-FTN (equivalent dose for PCA bolus)

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

    Drug: Sublingual Tablet

Interventions

  • DrugIntravenous Infusion

    IV PCA(fentanyl) Fentanyl bolus = MME \* 15%

    Also known as: PCA

  • DrugSublingual Tablet

    subligual fentanyl(Narco®) Fentanyl 100mcg/200mcg/300mcg according to the around-the-clock opioid requirement.

    Also known as: sublingual

05

What researchers measure

Primary outcomes

  1. 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"

    Time frame: 30 minutes after administration

Secondary outcomes

  1. 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"

    Time frame: 15, 45, 60 minutes after administration

  2. sum of pain intensity difference(SPID)

    sum of pain intensity change compared to baseline difference

    Time frame: 60 minutes after administration

  3. number of additional doses

    number of additional doses fentanyl bolus or subligual

    Time frame: immediately after the intervention

  4. Pain interference

    Pain interference using BPI-SF

    Time frame: immediately after the intervention

  5. Insomnia

    The severity of insomnia using ISI

    Time frame: immediately after the intervention

  6. 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

    Time frame: immediately after the intervention

  7. Satisfaction scale

    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

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT05053308
Lead sponsor
Seoul National University
Responsible party
Jeeyoun Moon (Associate Professor, Seoul National University) — Principal investigator
First posted
Sep 22, 2021
Start date
Dec 1, 2022 (estimated)
Primary completion
May 31, 2023 (estimated)
Completion
Dec 31, 2023 (estimated)
Last update
Aug 7, 2023

Study contacts

Jee Youn Moon, MD, PhD
study chair · Seoul National University Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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