Cancer PainNCT05053308
Proportional Dose of Sublingual Fentanyl Tablet Based on Daily Opioid Requirement
A study testing Intravenous Infusion and Sublingual Tablet in people with Cancer Pain and Breakthrough Pain, run by Seoul National University.
Trial 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 more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Cancer Pain, Breakthrough Pain
- What is being tested?
- Intravenous Infusion and Sublingual Tablet
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2022to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Noncancer pain
- Opioid naive
- baseline NRS pain score> 4
- Current using sublingual fentanyl
- Difficult to assess cancer pain
- no evidence of disease(cancer)
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- Planned surgical resection of cancer
- Allergy to fentanyl
- Severe renal and/or liver function
- Severe respiratory depression or uncontrolled COPD
About this study
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
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.
- Conditions
- Cancer Pain, Breakthrough Pain
- Being tested
- Intravenous Infusion, Sublingual Tablet
- Medical subject headings
- Cancer Pain, Breakthrough Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous InfusionDrug
Also called PCA
IV PCA(fentanyl) Fentanyl bolus = MME * 15%
Sublingual TabletDrug
Also called sublingual
subligual fentanyl(Narco®) Fentanyl 100mcg/200mcg/300mcg according to the around-the-clock opioid requirement.
| Study group | Role | What they receive |
|---|---|---|
| IV PCA (proportional dosage) | Active comparator | Breakthrough pain control by bolus based IV patient-controlled anagesia Fentanyl bolus = MME * 15% Receives: Drug: Intravenous Infusion |
| SL-FTN (equivalent dose for PCA bolus) | Experimental | Breakthrough pain control by sublingual fentanyl Fentanyl 100mcg/200mcg/300mcg according to the around-the-clock opioid requirement. Receives: Drug: Sublingual Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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"
Measured: 30 minutes after administration
Secondary outcomes (7)
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"
Measured: 15, 45, 60 minutes after administration
sum of pain intensity difference(SPID)
sum of pain intensity change compared to baseline difference
Measured: 60 minutes after administration
number of additional doses
number of additional doses fentanyl bolus or subligual
Measured: immediately after the intervention
Pain interference
Pain interference using BPI-SF
Measured: immediately after the intervention
Insomnia
The severity of insomnia using ISI
Measured: immediately after the intervention
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
Measured: immediately after the intervention
Satisfaction scale
Satisfaction check using 5 Likert-scale
(1) Very dissatisfied; (2) Not satisfied; (3) Neutral; (4) Satisfied; (5) Very satidfied
Measured: immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2021
- Study start1 Dec 2022 (estimated)
- Primary completion31 May 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Why it stopped: The supply of IP is disrupted
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeeyoun Moon, Seoul National University
- Investigators
- Jee Youn Moon, MD, PhD, Study chair, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05053308
- Sponsor's protocol ID
- 2012-144-1183
- Status last verified
- Aug 2023
- First submitted
- 30 Aug 2021
- Last updated
- 7 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05053308
- Acronym / sponsor ID
- 2012-144-1183
- Conditions
- Cancer Pain, Breakthrough Pain
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The supply of IP is disrupted
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Seoul National UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (estimated)
- Primary completion
- 31 May 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 22 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IV PCA (proportional dosage) | Active comparator | Drug: Intravenous InfusionBreakthrough pain control by bolus based IV patient-controlled anagesia Fentanyl bolus = MME * 15% |
| SL-FTN (equivalent dose for PCA bolus) | Experimental | Drug: Sublingual TabletBreakthrough pain control by sublingual fentanyl Fentanyl 100mcg/200mcg/300mcg according to the around-the-clock opioid requirement. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- Noncancer pain
- Opioid naive
- baseline NRS pain score> 4
- Current using sublingual fentanyl
- Difficult to assess cancer pain
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravenous InfusionAlso: PCAIV PCA(fentanyl) Fentanyl bolus = MME * 15% | Drug | IV PCA (proportional dosage) |
| Sublingual TabletAlso: sublingualsubligual fentanyl(Narco®) Fentanyl 100mcg/200mcg/300mcg according to the around-the-clock opioid requirement. | Drug | SL-FTN (equivalent dose for PCA bolus) |
Primary outcome
Change in 11-point scale NRS pain score
Time frame: 30 minutes after administration
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"
7 secondary outcomes
Change in 11-point scale NRS pain score
Time frame: 15, 45, 60 minutes after administration
sum of pain intensity difference(SPID)
Time frame: 60 minutes after administration
number of additional doses
Time frame: immediately after the intervention
Pain interference
Time frame: immediately after the intervention
Insomnia
Time frame: immediately after the intervention
Depression
Time frame: immediately after the intervention
Satisfaction scale
Time frame: immediately after the intervention
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jee Youn Moon, MD, PhD study chair
Seoul National University Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Intravenous Infusion and Sublingual Tablet in people with Cancer Pain and Breakthrough Pain, run by Seoul National University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 11-point scale NRS pain score (time frame: 30 minutes after administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2023.